Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

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

maanantai 25. maaliskuuta 2019 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Havainnollistava

Ilmoittautuminen (Todellinen)

101

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

15 vuotta - 22 vuotta (Lapsi, Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Joo

Sukupuolet, jotka voivat opiskella

Uros

Näytteenottomenetelmä

Ei-todennäköisyysnäyte

Tutkimusväestö

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.

Kuvaus

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).

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Kohortit ja interventiot

Ryhmä/Kohortti
Interventio / Hoito
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.
Lääke: 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.
Muut nimet:
  • Truvada®

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Magnitude of Change (Fold Change) in Parathyroid Hormone (PTH) From Baseline to Week 48
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

University of North Carolina, Chapel Hill

Yhteistyökumppanit

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

Tutkijat

  • Opintojen puheenjohtaja: Peter Havens, MD, MACC Fund Research Center

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus

Torstai 1. marraskuuta 2012

Ensisijainen valmistuminen (Todellinen)

Sunnuntai 1. marraskuuta 2015

Opintojen valmistuminen (Todellinen)

Sunnuntai 1. marraskuuta 2015

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Maanantai 14. tammikuuta 2013

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Maanantai 14. tammikuuta 2013

Ensimmäinen Lähetetty (Arvio)

Keskiviikko 16. tammikuuta 2013

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 27. maaliskuuta 2019

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 25. maaliskuuta 2019

Viimeksi vahvistettu

Torstai 1. marraskuuta 2018

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • ATN 117 Version 2.0

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Tilaa