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Renal, Endocrine, and Bone Changes in Response to FTC/TDF in Uninfected Young Men Who Have Sex With Men (YMSM).

25 marzo 2019 aggiornato da: University of North Carolina, Chapel Hill

Renal, Endocrine, and Bone Changes in Response to Treatment With Coformulated Emtricitabine-Tenofovir for Pre-Exposure HIV Prophylaxis (PrEP) in HIV Uninfected Young Men Who Have Sex With Men.

This is a prospective observational cohort sub-study of subjects enrolled in the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 110 (NCT01772823) or ATN 113 (NCT01769456), which is a prospective interventional trial.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a prospective observational cohort sub-study of subjects enrolled in the ATN 110 (NCT01772823) or ATN 113 (NCT01769456) study. All subjects will be followed for at least 48 weeks. Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 (NCT01772823) or ATN 113 (NCT01769456) study will be followed for an additional 48 weeks in the Extension Phase of ATN 110 (NCT01772823) or ATN 113 (NCT01769456) and ATN 117 (NCT01769469). The maximum duration of participation will be 96 weeks.

There is no therapeutic intervention specific to this sub-study, and there are no extra study visits required for participation in this sub-study. Questionnaires will be administered and blood and urine samples for laboratory evaluation of potential emtricitabine (FTC)/tenofovir (TDF) (Truvada®) toxicities will be obtained for this sub-study at visits that are required by the ATN 110 (NCT01772823) or ATN 113 (NCT01769456) study. Measurement of bone mineral density (BMD) and bone mineral content (BMC) by dual-energy X-ray absorptiometry (DXA) scan are planned as a part of the ATN 110 (NCT01772823) and ATN 113 (NCT01769456) studies, and results will be utilized for the analysis in this study. This study does not require extra BMD or BMC measurements.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

101

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • California
      • Los Angeles, California, Stati Uniti, 90027
        • Children's Hopsital of Los Angeles
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
        • Children's Hospital of Denver
    • Florida
      • Miami, Florida, Stati Uniti, 33101
        • University of Miami
      • Tampa, Florida, Stati Uniti, 33606
        • University of South Florida
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60612
        • Stroger Hospital and the CORE Center
    • Louisiana
      • New Orleans, Louisiana, Stati Uniti, 70112
        • Tulane University
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21287
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02215
        • Fenway Institute
    • Michigan
      • Detroit, Michigan, Stati Uniti, 48201
        • Wayne State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • Children's Hopsital of Philadelphia
    • Tennessee
      • Memphis, Tennessee, Stati Uniti, 38105
        • St. Jude Childrens Research Hospital
    • Texas
      • Houston, Texas, Stati Uniti, 77030
        • Baylor College of Medicine

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 15 anni a 22 anni (Bambino, Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Maschio

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Individuals between the ages 15 years 0 days to 22 years 364 days, who are enrolled in ATN 110 (NCT01772823) or ATN 113 (NCT01769456) , and agree to enter this sub-study at the same time they begin ATN 110 or ATN 113.

Descrizione

Inclusion Criteria:

  • Has been enrolled in ATN 110 (NCT01772823) or ATN 113 (NCT01769456) , and
  • Willing and able to provide written informed consent

Exclusion Criteria:

-Subjects exempted from undergoing DXA scans in ATN 110 (NCT01772823) or ATN 113 (NCT01769456) are not eligible to enroll in ATN 117 (NCT01769469).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Subjects Enrolled in ATN 110 or ATN 113
A subset of 100 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.
Droga: FTC/TDF (Truvada®)
There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.
Altri nomi:
  • Truvada®

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Magnitude of Change (Fold Change) in Parathyroid Hormone (PTH) From Baseline to Week 48
Lasso di tempo: Baseline and Week (wk) 48
The magnitude of change in PTH will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Baseline and Week (wk) 48

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Change From Baseline to Week 48
Lasso di tempo: Baseline and wk 48
Baseline and wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Magnitude of Fold Change
Lasso di tempo: Baseline and wk 48
The magnitude of change in FGF23 will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Baseline and wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Most Extreme Fold Change
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Baseline, Weeks 4, 8, 12, 24, 36 and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Time to Most Extreme Fold Change
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 Dihydroxy Vitamin D (1,25 OHD), Change From Baseline to Week 48
Lasso di tempo: Baseline and wk 48
Baseline and wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Magnitude of Fold Change
Lasso di tempo: Baseline and wk 48
The magnitude of change in 1,25 OHD will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Baseline and wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Most Extreme Fold Change
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Baseline, Weeks 4, 8, 12, 24, 36 and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Time to Most Extreme Fold Change
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Tubular Reabsorption of Phosphate (TRP), Change From Baseline to Week 48
Lasso di tempo: Baseline and wk 48
Baseline and wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Magnitude of Fold Change
Lasso di tempo: Baseline and wk 48
The magnitude of change in TRP will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Baseline and wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Most Extreme Fold Change
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Baseline, Weeks 4, 8, 12, 24, 36 and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Time to Most Extreme Fold Change
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Glomerular Filtration Rate (GFR), Change From Baseline to Week 48
Lasso di tempo: Baseline and wk 48
Baseline and wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Magnitude of Fold Change
Lasso di tempo: Baseline and wk 48
The magnitude of change in GFR will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Baseline and wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Most Extreme Fold Change
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Baseline, Weeks 4, 8, 12, 24, 36 and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Time to Most Extreme Fold Change
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Most Extreme Fold Change
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Baseline, Weeks 4, 8, 12, 24, 36 and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Time to Most Extreme Fold Change
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Serum Creatinine (SCr), Time to Most Extreme Fold Change
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Slope of the Curve of Baseline to Most Extreme Fold Change
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48

The slope from baseline to most extreme fold change can be expressed as:

Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: FGF23, Slope of the Curve of Baseline to Most Extreme Fold Change
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48

The slope from baseline to most extreme fold change can be expressed as:

Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25-OHD, Slope of the Curve of Baseline to Most Extreme Fold Change
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48

The slope from baseline to most extreme fold change can be expressed as:

Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Slope of the Curve of Baseline to Most Extreme Fold Change
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48

The slope from baseline to most extreme fold change can be expressed as:

Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change From Baseline to Week 48 in Serum Calcium (SCa)
Lasso di tempo: Baseline and wk 48
Serum calcium Week 48 difference from baseline
Baseline and wk 48
Magnitude of Most Extreme Fold Change: Serum Calcium (SCa)
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Time to Most Extreme Fold Change: Serum Calcium (SCa)
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Slope of the Curve of Baseline to Most Extreme Fold Change: Serum Calcium (SCa)
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48

The slope from baseline to most extreme fold change can be expressed as:

Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change From Baseline to Week 48 in Urine Calcium (UCa) / Urine Creatinine (UCr)
Lasso di tempo: Baseline and wk 48
Urine Calcium (UCa) / Urine Creatinine (UCr) ratio Week 48 difference from baseline
Baseline and wk 48
Magnitude of Most Extreme Fold Change: UCa/UCr Ratio
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Time to Most Extreme Fold Change: UCa/UCr Ratio
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Slope of the Curve of Baseline to Most Extreme Fold Change: UCa/UCr Ratio
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48

The slope from baseline to most extreme fold change can be expressed as:

Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change From Baseline to Week 48 in Serum Phosphate (SPO4)
Lasso di tempo: Baseline and wk 48
Serum Phosphate (SPO4) Week 48 difference from baseline
Baseline and wk 48
Magnitude of Most Extreme Fold Change: SPO4
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Time to Most Extreme Fold Change: SPO4
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Slope of the Curve of Baseline to Most Extreme Fold Change: SPO4
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48

The slope from baseline to most extreme fold change can be expressed as:

Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)
Lasso di tempo: Baseline and wk 48
URBP/UCr Week 48 difference from baseline
Baseline and wk 48
Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Beta-2 Microglobulin (UB2MG)
Lasso di tempo: Baseline and wk 48
UB2MG Week 48 difference from baseline
Baseline and wk 48
Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Protein (UProt) / Urine Creatinine (UCr)
Lasso di tempo: Baseline and wk 48
UProt/ UCr Week 48 difference from baseline
Baseline and wk 48
Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Glucose (UGluc)
Lasso di tempo: Baseline and wk 48
UGluc Week 48 difference from baseline
Baseline and wk 48
Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Serum Creatinine (SCr)
Lasso di tempo: Baseline and wk 48
SCr Week 48 difference from baseline
Baseline and wk 48
Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)
Lasso di tempo: Baseline and wk 48
The magnitude of change in URBP/UCr will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Baseline and wk 48
Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Beta-2 Microglobulin (UB2MG)
Lasso di tempo: Baseline and wk 48
The magnitude of change in UB2MG will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Baseline and wk 48
Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Protein (UProt)/ Urine Creatinine (UCr)
Lasso di tempo: Baseline and wk 48
The magnitude of change in UProt/UCr will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Baseline and wk 48
Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Glucose (UGluc)
Lasso di tempo: Baseline and wk 48
The magnitude of change in UGluc will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Baseline and wk 48
Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Serum Creatinine (SCr)
Lasso di tempo: Baseline and wk 48
The magnitude of change in SCr will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Baseline and wk 48
Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Baseline, Weeks 4, 8, 12, 24, 36 and 48
Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UB2MG
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Baseline, Weeks 4, 8, 12, 24, 36 and 48
Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UProt/UCr
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Baseline, Weeks 4, 8, 12, 24, 36 and 48
Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UGluc
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Baseline, Weeks 4, 8, 12, 24, 36 and 48
Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in SCr
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Baseline, Weeks 4, 8, 12, 24, 36 and 48
Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UB2MG
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UProt/UCr
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UGluc
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48

The slope from baseline to most extreme fold change can be expressed as:

Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UB2MG
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48

The slope from baseline to most extreme fold change can be expressed as:

Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UProt/UCr
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48

The slope from baseline to most extreme fold change can be expressed as:

Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UGluc
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48

The slope from baseline to most extreme fold change can be expressed as:

Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in Scr
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48

The slope from baseline to most extreme fold change can be expressed as:

Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Change From Baseline to Week 48 in Osteocalcin (OC)
Lasso di tempo: Baseline and wk 48
OC Week 48 difference from baseline
Baseline and wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Change From Baseline to Week 48 in C-Telopeptide (CTX)
Lasso di tempo: Baseline and wk 48
CTX Week 48 difference from baseline
Baseline and wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Most Extreme Fold Change in Osteocalcin (OC)
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Baseline, Weeks 4, 8, 12, 24, 36 and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Most Extreme Fold Change in C-telopeptide (CTX)
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Baseline, Weeks 4, 8, 12, 24, 36 and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: OC, Time to Most Extreme Fold Change
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Time to Most Extreme Fold Change in C-telopeptide (CTX)
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Slope of the Curve of Baseline to Most Extreme Fold Change in OC
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, 36, and 48

The slope from baseline to most extreme fold change can be expressed as:

Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Slope of the Curve of Baseline to Most Extreme Fold Change in CTX
Lasso di tempo: Baseline, Weeks (wks) 4, 8, 12, 24, 36, and 48

The slope from baseline to most extreme fold change can be expressed as:

Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]
Baseline, Weeks (wks) 4, 8, 12, 24, 36, and 48
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in PTH, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 48

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in PTH, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 24

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, and 24.
Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in FGF23, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 24

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, and 24.
Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in FGF23, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 48

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in 1,25 OHD, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 24

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, and 24.
Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in 1,25 OHD, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 48

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in Osteocalcin (OC), by Overall Drug Exposure
Lasso di tempo: Baseline and wk 24

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, and 24.
Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in Osteocalcin (OC), by Overall Drug Exposure
Lasso di tempo: Baseline and wk 48

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in CTX, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 24

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, and 24.
Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in CTX, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 48

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in SCr, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 24

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, and 24.
Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in SCr, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 48

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in TRP, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 24

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, and 24.
Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in TRP, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 48

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UCa/UCr Ratio, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 24

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, and 24.
Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UCa/UCr Ratio, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 48

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UB2MG, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 24

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, and 24.
Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UB2MG, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 48

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UGluc, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 24

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, and 24.
Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UGluc, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 48

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in URBP/UCr Ratio, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 24

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, and 24.
Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in URBP/UCr Ratio, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 48

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Lumbar Spine BMD, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 24

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, and 24.
Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Lumbar Spine BMD, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 48

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in Lumbar Spine BMD Z-score, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 24

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.

The time points at which data were collected were: weeks 4, 8, 12, and 24.
Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in Lumbar Spine BMD Z-score, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 48

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.

The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Femoral Neck BMD, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 24

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, and 24.
Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Femoral Neck BMD, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 48

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in Femoral Neck BMD Z-score, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 24

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.

The time points at which data were collected were: weeks 4, 8, 12, and 24.
Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in Femoral Neck BMD Z-score, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 48

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.

The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Total Body BMC, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 24

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, and 24.
Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Total Body BMC, by Overall Drug Exposure
Lasso di tempo: Baseline and wk 48

Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.

The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Baseline and wk 48
Magnitude of Change in Lumbar Spine BMD at Week 48
Lasso di tempo: Baseline and wk 48
The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Baseline and wk 48
Magnitude of Change in Lumbar Spine BMD Z-score at Week 48
Lasso di tempo: Baseline and wk 48

The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).

The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.
Baseline and wk 48
Magnitude of Change in Femoral Neck BMD at Week 48
Lasso di tempo: Baseline and wk 48
The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Baseline and wk 48
Magnitude of Change in Femoral Neck BMD Z-score at Week 48
Lasso di tempo: Baseline and wk 48
The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Baseline and wk 48
Magnitude of Change in Total Body BMC at Week 48
Lasso di tempo: Baseline and wk 48
The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Baseline and wk 48
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH1 From Baseline
Lasso di tempo: Baseline and wk 72

For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).

This measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1)
Baseline and wk 72
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH2 From Baseline
Lasso di tempo: Baseline and wk 96

For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).

This measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)
Baseline and wk 96
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH1 From Week 48 (or Last Visit on Study)
Lasso di tempo: Wk 48 (or last available measurement on study), Wk 72

For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).

This measure shows the difference between the last measure on study and the first Extension Phase visit (Last - EPH1)
Wk 48 (or last available measurement on study), Wk 72
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH2 From Week 48 (or Last Visit on Study)
Lasso di tempo: Wk 48 (or last available measurement on study), Wk 96

For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).

This measure shows the difference between the last measure on study and the second Extension Phase visit (Last - EPH2)
Wk 48 (or last available measurement on study), Wk 96
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH1 From Baseline
Lasso di tempo: Baseline and wk 72

For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).

This measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1).

The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.
Baseline and wk 72
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH2 From Baseline
Lasso di tempo: Baseline and wk 96

For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).

This measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)

The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.
Baseline and wk 96
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH1 From Week 48 (or Last Visit on Study)
Lasso di tempo: Wk 48 (or last available measurement on study), Wk 72

For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).

This measure shows the difference between the last measure on study and the first Extension Phase visit (Last - EPH1)

The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.
Wk 48 (or last available measurement on study), Wk 72
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH2 From Week 48 (or Last Visit on Study)
Lasso di tempo: Wk 48 (or last available measurement on study), Wk 96

For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).

This measure shows the difference between the last measure on study and the second Extension Phase visit (Last - EPH2)

The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.
Wk 48 (or last available measurement on study), Wk 96
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH1 From Baseline
Lasso di tempo: Baseline and wk 72

For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).

This measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1)
Baseline and wk 72
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH2 From Baseline
Lasso di tempo: Baseline and wk 96

For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).

This measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)
Baseline and wk 96
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH1 From Week 48 (or Last Visit on Study)
Lasso di tempo: Wk 48 (or last available measurement on study), Wk 72

For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).

This measure shows the difference between the last measure on study and the first Extension Phase visit (Last- EPH1)
Wk 48 (or last available measurement on study), Wk 72
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH2 From Week 48 (or Last Visit on Study)
Lasso di tempo: W 48 (or last available measurement on study), Wk 96

For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).

This measure shows the difference between the last measure on study and the second Extension Phase visit (Last- EPH2)
W 48 (or last available measurement on study), Wk 96
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH1 From Baseline
Lasso di tempo: Baseline and wk 72

For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).

This measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1)

The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.
Baseline and wk 72
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH2 From Baseline
Lasso di tempo: Baseline, Week 96

For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).

This measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)

The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.
Baseline, Week 96
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH1 From Week 48 (or Last Visit on Study)
Lasso di tempo: Week 48 (or last available measurement on study), Week 72

For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).

This measure shows the difference between the last measure on study and the first Extension Phase visit (Last - EPH1)

The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.
Week 48 (or last available measurement on study), Week 72
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH2 From Week 48 (or Last Visit on Study)
Lasso di tempo: Wk 48 (or last available measurement on study), Wk 96

For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).

This measure shows the difference between the last measure on study and the second Extension Phase visit (Last - EPH2).

The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.
Wk 48 (or last available measurement on study), Wk 96
Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH1 From Baseline
Lasso di tempo: Baseline and wk 72

For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).

This measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1)
Baseline and wk 72
Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH2 From Baseline
Lasso di tempo: Baseline and wk 96

For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).

This measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)
Baseline and wk 96
Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH1 From Week 48 (or Last Visit on Study)
Lasso di tempo: Wk 48 (or last available measurement on study), Wk 72

For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).

This measure shows the difference between the last measure on study and the first Extension Phase visit (Last- EPH1)
Wk 48 (or last available measurement on study), Wk 72
Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH2 From Week 48 (or Last Visit on Study)
Lasso di tempo: Wk 48 (or last available measurement on study), Wk 96

For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).

This measure shows the difference between the last measure on study and the second Extension Phase visit (Last- EPH2)
Wk 48 (or last available measurement on study), Wk 96

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of North Carolina, Chapel Hill

Collaboratori

National Institute on Drug Abuse (NIDA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)

Investigatori

  • Cattedra di studio: Peter Havens, MD, MACC Fund Research Center

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2012

Completamento primario (Effettivo)

1 novembre 2015

Completamento dello studio (Effettivo)

1 novembre 2015

Date di iscrizione allo studio

Primo inviato

14 gennaio 2013

Primo inviato che soddisfa i criteri di controllo qualità

14 gennaio 2013

Primo Inserito (Stima)

16 gennaio 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 marzo 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 marzo 2019

Ultimo verificato

1 novembre 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ATN 117 Version 2.0

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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