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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 maart 2019 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

101

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

15 jaar tot 22 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Mannelijk

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Geneesmiddel: 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.
Andere namen:
  • Truvada®

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Magnitude of Change (Fold Change) in Parathyroid Hormone (PTH) From Baseline to Week 48
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Change From Baseline to Week 48
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline and wk 48
Baseline and wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Magnitude of Fold Change
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline and wk 48
Baseline and wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Magnitude of Fold Change
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline and wk 48
Baseline and wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Magnitude of Fold Change
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: Baseline and wk 48
Serum calcium Week 48 difference from baseline
Baseline and wk 48
Magnitude of Most Extreme Fold Change: Serum Calcium (SCa)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: Baseline and wk 48
Serum Phosphate (SPO4) Week 48 difference from baseline
Baseline and wk 48
Magnitude of Most Extreme Fold Change: SPO4
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of North Carolina, Chapel Hill

Medewerkers

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

Onderzoekers

  • Studie stoel: Peter Havens, MD, MACC Fund Research Center

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2012

Primaire voltooiing (Werkelijk)

1 november 2015

Studie voltooiing (Werkelijk)

1 november 2015

Studieregistratiedata

Eerst ingediend

14 januari 2013

Eerst ingediend dat voldeed aan de QC-criteria

14 januari 2013

Eerst geplaatst (Schatting)

16 januari 2013

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 maart 2019

Laatste update ingediend die voldeed aan QC-criteria

25 maart 2019

Laatst geverifieerd

1 november 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ATN 117 Version 2.0

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