HIV Infection
Conditions
Keywords
Tenofovir, Emtricitabine, Truvada, Renal, endocrine, bone changes, HIV prevention, PrEP
Brief summary
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.
Detailed description
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.
Interventions
DRUGFTC/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.
Sponsors
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of North Carolina, Chapel Hill
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
15 Years to 22 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Magnitude of Change (Fold Change) in Parathyroid Hormone (PTH) From Baseline to Week 48 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Magnitude of Fold Change | 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). |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Most Extreme Fold Change | 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. |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Time to Most Extreme Fold Change | 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. |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 Dihydroxy Vitamin D (1,25 OHD), Change From Baseline to Week 48 | Baseline and wk 48 | — |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Magnitude of Fold Change | 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). |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Most Extreme Fold Change | 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. |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Time to Most Extreme Fold Change | 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. |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Tubular Reabsorption of Phosphate (TRP), Change From Baseline to Week 48 | Baseline and wk 48 | — |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Magnitude of Fold Change | 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). |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Most Extreme Fold Change | 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. |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Time to Most Extreme Fold Change | 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. |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Glomerular Filtration Rate (GFR), Change From Baseline to Week 48 | Baseline and wk 48 | — |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Magnitude of Fold Change | 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). |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Most Extreme Fold Change | 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. |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Time to Most Extreme Fold Change | 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. |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Most Extreme Fold Change | 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. |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Time to Most Extreme Fold Change | 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. |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Serum Creatinine (SCr), Time to Most Extreme Fold Change | 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. |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Slope of the Curve of Baseline to Most Extreme Fold Change | Baseline, Weeks 4, 8, 12, 24, 36, and 48 | The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\] |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: FGF23, Slope of the Curve of Baseline to Most Extreme Fold Change | Baseline, Weeks 4, 8, 12, 24, 36, and 48 | The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\] |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25-OHD, Slope of the Curve of Baseline to Most Extreme Fold Change | Baseline, Weeks 4, 8, 12, 24, 36, and 48 | The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\] |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Slope of the Curve of Baseline to Most Extreme Fold Change | Baseline, Weeks 4, 8, 12, 24, 36, and 48 | The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\] |
| Change From Baseline to Week 48 in Serum Calcium (SCa) | Baseline and wk 48 | Serum calcium Week 48 difference from baseline |
| Magnitude of Most Extreme Fold Change: Serum Calcium (SCa) | 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. |
| Time to Most Extreme Fold Change: Serum Calcium (SCa) | 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. |
| Slope of the Curve of Baseline to Most Extreme Fold Change: Serum Calcium (SCa) | Baseline, Weeks 4, 8, 12, 24, 36, and 48 | The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\] |
| Change From Baseline to Week 48 in Urine Calcium (UCa) / Urine Creatinine (UCr) | Baseline and wk 48 | Urine Calcium (UCa) / Urine Creatinine (UCr) ratio Week 48 difference from baseline |
| Magnitude of Most Extreme Fold Change: UCa/UCr Ratio | 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. |
| Time to Most Extreme Fold Change: UCa/UCr Ratio | 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. |
| Slope of the Curve of Baseline to Most Extreme Fold Change: UCa/UCr Ratio | Baseline, Weeks 4, 8, 12, 24, 36, and 48 | The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\] |
| Change From Baseline to Week 48 in Serum Phosphate (SPO4) | Baseline and wk 48 | Serum Phosphate (SPO4) Week 48 difference from baseline |
| Magnitude of Most Extreme Fold Change: SPO4 | 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. |
| Time to Most Extreme Fold Change: SPO4 | 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. |
| Slope of the Curve of Baseline to Most Extreme Fold Change: SPO4 | Baseline, Weeks 4, 8, 12, 24, 36, and 48 | The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\] |
| Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr) | Baseline and wk 48 | URBP/UCr Week 48 difference from baseline |
| Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Beta-2 Microglobulin (UB2MG) | Baseline and wk 48 | UB2MG Week 48 difference from baseline |
| Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Protein (UProt) / Urine Creatinine (UCr) | Baseline and wk 48 | UProt/ UCr Week 48 difference from baseline |
| Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Glucose (UGluc) | Baseline and wk 48 | UGluc Week 48 difference from baseline |
| Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Serum Creatinine (SCr) | Baseline and wk 48 | SCr Week 48 difference from baseline |
| Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr) | 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). |
| Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Beta-2 Microglobulin (UB2MG) | 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). |
| Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Protein (UProt)/ Urine Creatinine (UCr) | 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). |
| Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Glucose (UGluc) | 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). |
| Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Serum Creatinine (SCr) | 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). |
| Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr) | 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. |
| Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UB2MG | 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. |
| Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UProt/UCr | 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. |
| Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UGluc | 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. |
| Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in SCr | 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. |
| Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr) | 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. |
| Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UB2MG | 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. |
| Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UProt/UCr | 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. |
| Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UGluc | 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. |
| 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) | Baseline, Weeks 4, 8, 12, 24, 36, and 48 | The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\] |
| Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UB2MG | Baseline, Weeks 4, 8, 12, 24, 36, and 48 | The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\] |
| Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UProt/UCr | Baseline, Weeks 4, 8, 12, 24, 36, and 48 | The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\] |
| Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UGluc | Baseline, Weeks 4, 8, 12, 24, 36, and 48 | The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\] |
| Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in Scr | Baseline, Weeks 4, 8, 12, 24, 36, and 48 | The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\] |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Change From Baseline to Week 48 in Osteocalcin (OC) | Baseline and wk 48 | OC Week 48 difference from baseline |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Change From Baseline to Week 48 in C-Telopeptide (CTX) | Baseline and wk 48 | CTX Week 48 difference from baseline |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Most Extreme Fold Change in Osteocalcin (OC) | 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. |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Most Extreme Fold Change in C-telopeptide (CTX) | 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. |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: OC, Time to Most Extreme Fold Change | 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. |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Time to Most Extreme Fold Change in C-telopeptide (CTX) | 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. |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Slope of the Curve of Baseline to Most Extreme Fold Change in OC | Baseline, Weeks 4, 8, 12, 24, 36, and 48 | The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\] |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Slope of the Curve of Baseline to Most Extreme Fold Change in CTX | Baseline, Weeks (wks) 4, 8, 12, 24, 36, and 48 | The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\] |
| Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in PTH, by Overall Drug Exposure | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in PTH, by Overall Drug Exposure | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in FGF23, by Overall Drug Exposure | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in FGF23, by Overall Drug Exposure | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in 1,25 OHD, by Overall Drug Exposure | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in 1,25 OHD, by Overall Drug Exposure | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in Osteocalcin (OC), by Overall Drug Exposure | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in Osteocalcin (OC), by Overall Drug Exposure | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in CTX, by Overall Drug Exposure | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in CTX, by Overall Drug Exposure | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in SCr, by Overall Drug Exposure | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in SCr, by Overall Drug Exposure | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in TRP, by Overall Drug Exposure | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in TRP, by Overall Drug Exposure | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UCa/UCr Ratio, by Overall Drug Exposure | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UCa/UCr Ratio, by Overall Drug Exposure | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UB2MG, by Overall Drug Exposure | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UB2MG, by Overall Drug Exposure | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UGluc, by Overall Drug Exposure | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UGluc, by Overall Drug Exposure | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in URBP/UCr Ratio, by Overall Drug Exposure | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in URBP/UCr Ratio, by Overall Drug Exposure | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Lumbar Spine BMD, by Overall Drug Exposure | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Lumbar Spine BMD, by Overall Drug Exposure | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Total Body BMC, by Overall Drug Exposure | 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. |
| 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 | 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. |
| Magnitude of Change in Lumbar Spine BMD at Week 48 | 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). |
| 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 | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Femoral Neck BMD, by Overall Drug Exposure | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Femoral Neck BMD, by Overall Drug Exposure | 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. |
| 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 | 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. |
| 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 | 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. |
| Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Total Body BMC, by Overall Drug Exposure | 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. |
| Magnitude of Change in Lumbar Spine BMD Z-score at Week 48 | 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. |
| Magnitude of Change in Femoral Neck BMD at Week 48 | 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). |
| Magnitude of Change in Femoral Neck BMD Z-score at Week 48 | 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). |
| Magnitude of Change in Total Body BMC at Week 48 | 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). |
| Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH1 From Baseline | 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) |
| Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH2 From Baseline | 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) |
| Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH1 From Week 48 (or Last Visit on Study) | 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) |
| Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH2 From Week 48 (or Last Visit on Study) | 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) |
| Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH1 From Baseline | 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. |
| Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Change From Baseline to Week 48 | Baseline and wk 48 | — |
| Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH1 From Week 48 (or Last Visit on Study) | 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. |
| Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH2 From Week 48 (or Last Visit on Study) | 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. |
| Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH1 From Baseline | 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) |
| Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH2 From Baseline | 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) |
| Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH1 From Week 48 (or Last Visit on Study) | 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) |
| Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH2 From Week 48 (or Last Visit on Study) | 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) |
| Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH1 From Baseline | 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. |
| Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH2 From Baseline | 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. |
| Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH1 From Week 48 (or Last Visit on Study) | 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) |
| Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH1 From Week 48 (or Last Visit on Study) | 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. |
| Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH2 From Week 48 (or Last Visit on Study) | 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) |
| Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH2 From Week 48 (or Last Visit on Study) | 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. |
| Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH1 From Baseline | 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) |
| Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH2 From Baseline | 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) |
| Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH2 From Baseline | 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. |
Countries
United States
Participant flow
Recruitment details
The research was conducted at 11 clinical sites. Accrual was open between November 2012 and December 2013.
Participants by arm
| Arm | Count |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 A subset of 101 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.
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. | 101 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Consent Withdrawn | 5 |
| Overall Study | Lost to Follow-up | 17 |
| Overall Study | Moved Out Of Area | 3 |
| Overall Study | Prem D/C from ATN 110/113 For Any Reason | 7 |
| Overall Study | Subject Confirmed HIV Positive | 3 |
Baseline characteristics
| Characteristic | Subjects Enrolled in ATN 110 or ATN 113 |
|---|---|
| 1,25-dihydroxy vitamin D (1,25-OHD RIA) | 160.71 pmol/L |
| Actual Free 123(OH)D | 994.88 fmol/L |
| Age, Continuous | 19.62 years STANDARD_DEVIATION 1.8 |
| C-telopeptide (CTX) | 935.76 pg/mL |
| Estimated glomerular filtration rate (eGFR) | 127.50 mL/min/1.73^2 |
| Femoral neck bone mineral density (BMD) | 1.03 g/cm^2 |
| Fibroblast growth factor 23 (FGF23) | 38.78 pg/mL |
| Lumbar spine bone mineral density (BMD) | 1.09 g/cm^2 |
| Osteocalcin (OC) | 9.50 mcg/L |
| Parathyroid hormone (PTH) | 27.07 pg/mL |
| Race/Ethnicity, Customized Asian/Pacific Islander | 2 Participants |
| Race/Ethnicity, Customized Black/African American | 52 Participants |
| Race/Ethnicity, Customized Hispanic | 34 Participants |
| Race/Ethnicity, Customized Non-Black/African American | 49 Participants |
| Race/Ethnicity, Customized Non-Hispanic | 67 Participants |
| Race/Ethnicity, Customized Other/Mixed Race | 26 Participants |
| Race/Ethnicity, Customized White | 16 Participants |
| Race/Ethnicity, Customized White/Hispanic | 14 Participants |
| Serum Calcium (SCa) | 9.80 mg/dL |
| Serum Creatinine (SCr) | 0.86 mg/dL |
| Serum Phosphate (SPO4) | 1.16 mmol/L |
| Sex/Gender, Customized Male | 101 Participants |
| Total body bone mineral content (BMC) | 2690.83 g |
| Tubular reabsorption of phosphate (TRP) | 91.40 % (of filtered phosphorus reabsorbed) |
| Urinary Calcium/ Urinary Creatinine ratio (UCa/UCr) | 0.06 ratio |
| Urine beta-2 microglobulin (UB2MG) | 170.04 ng/mL |
| Urine Glucose (UGluc) | 0.07 mg/dL |
| Urine protein to urine creatinine ratio (UProt/UCr) | 0.05 ratio |
| Urine retinol binding protein to urine creatinine ratio (URBP/UCr) | 7092.50 mcg/g |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Magnitude of Change (Fold Change) in Parathyroid Hormone (PTH) From Baseline to Week 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).
Time frame: Baseline and Week (wk) 48
Population: Subjects with PTH data at baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Magnitude of Change (Fold Change) in Parathyroid Hormone (PTH) From Baseline to Week 48 | 1.08 fold change |
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in 1,25 OHD, by Overall Drug Exposure
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.
Time frame: Baseline and wk 24
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in 1,25 OHD, by Overall Drug Exposure | 10.80 pmol*wks/L |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in 1,25 OHD, by Overall Drug Exposure | 7.07 pmol*wks/L |
p-value: 0.8658Wilcoxon (Mann-Whitney)
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in CTX, by Overall Drug Exposure
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.
Time frame: Baseline and wk 24
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in CTX, by Overall Drug Exposure | 105.89 pM*wks |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in CTX, by Overall Drug Exposure | -25.90 pM*wks |
p-value: 0.122Wilcoxon (Mann-Whitney)
Secondary
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
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.
Time frame: Baseline and wk 24
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 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 | -0.10 z-score |
| Low Exposure Group | 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 | 0.00 z-score |
p-value: 0.0277Wilcoxon (Mann-Whitney)
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in FGF23, by Overall Drug Exposure
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.
Time frame: Baseline and wk 24
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in FGF23, by Overall Drug Exposure | -6.88 pg*wks/mL |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in FGF23, by Overall Drug Exposure | 0.79 pg*wks/mL |
p-value: 0.1134Wilcoxon (Mann-Whitney)
Secondary
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
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.
Time frame: Baseline and wk 24
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 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 | -0.10 z-score |
| Low Exposure Group | 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 | 0.00 z-score |
p-value: 0.2255Wilcoxon (Mann-Whitney)
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in Osteocalcin (OC), by Overall Drug Exposure
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.
Time frame: Baseline and wk 24
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in Osteocalcin (OC), by Overall Drug Exposure | 0.87 mcg*wks/L |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in Osteocalcin (OC), by Overall Drug Exposure | -1.03 mcg*wks/L |
p-value: 0.0238Wilcoxon (Mann-Whitney)
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in PTH, by Overall Drug Exposure
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.
Time frame: Baseline and wk 24
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in PTH, by Overall Drug Exposure | 0.46 pg*wks/mL |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in PTH, by Overall Drug Exposure | 0.47 pg*wks/mL |
p-value: 0.2927Wilcoxon (Mann-Whitney)
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in SCr, by Overall Drug Exposure
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.
Time frame: Baseline and wk 24
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in SCr, by Overall Drug Exposure | 0.02 mg*wks/dL |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in SCr, by Overall Drug Exposure | 0.00 mg*wks/dL |
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in TRP, by Overall Drug Exposure
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.
Time frame: Baseline and wk 24
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in TRP, by Overall Drug Exposure | 0.57 % of phosphorus reabsorbed*wks |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in TRP, by Overall Drug Exposure | 1.14 % of phosphorus reabsorbed*wks |
p-value: 0.4933Wilcoxon (Mann-Whitney)
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UB2MG, by Overall Drug Exposure
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.
Time frame: Baseline and wk 24
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UB2MG, by Overall Drug Exposure | -7.28 ng*wks/mL |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UB2MG, by Overall Drug Exposure | -23.29 ng*wks/mL |
p-value: 0.8579Wilcoxon (Mann-Whitney)
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UCa/UCr Ratio, by Overall Drug Exposure
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.
Time frame: Baseline and wk 24
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UCa/UCr Ratio, by Overall Drug Exposure | 0.00 ratio*weeks |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UCa/UCr Ratio, by Overall Drug Exposure | -0.01 ratio*weeks |
p-value: 0.5161Wilcoxon (Mann-Whitney)
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UGluc, by Overall Drug Exposure
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.
Time frame: Baseline and wk 24
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UGluc, by Overall Drug Exposure | -0.02 mg*wks/dL |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UGluc, by Overall Drug Exposure | 0.01 mg*wks/dL |
p-value: 0.3148Wilcoxon (Mann-Whitney)
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in URBP/UCr Ratio, by Overall Drug Exposure
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.
Time frame: Baseline and wk 24
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in URBP/UCr Ratio, by Overall Drug Exposure | -2281.71 mcg*wks/g |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in URBP/UCr Ratio, by Overall Drug Exposure | 808.53 mcg*wks/g |
p-value: 0.2726Wilcoxon (Mann-Whitney)
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in 1,25 OHD, by Overall Drug Exposure
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.
Time frame: Baseline and wk 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in 1,25 OHD, by Overall Drug Exposure | -12.55 pmol*wks/L |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in 1,25 OHD, by Overall Drug Exposure | -8.60 pmol*wks/L |
p-value: 0.5491Wilcoxon (Mann-Whitney)
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in CTX, by Overall Drug Exposure
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.
Time frame: Baseline and wk 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in CTX, by Overall Drug Exposure | 50.64 pM*wks |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in CTX, by Overall Drug Exposure | -20.72 pM*wks |
p-value: 1Wilcoxon (Mann-Whitney)
Secondary
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
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.
Time frame: Baseline and wk 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 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 | -0.10 z-score |
| Low Exposure Group | 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 | 0.10 z-score |
p-value: 0.261Wilcoxon (Mann-Whitney)
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in FGF23, by Overall Drug Exposure
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.
Time frame: Baseline and wk 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in FGF23, by Overall Drug Exposure | 1.66 pg*wks/mL |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in FGF23, by Overall Drug Exposure | 0.60 pg*wks/mL |
p-value: 0.5782Wilcoxon (Mann-Whitney)
Secondary
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
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.
Time frame: Baseline and wk 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 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 | -0.20 z-score |
| Low Exposure Group | 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 | -0.10 z-score |
p-value: 0.6285Wilcoxon (Mann-Whitney)
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in Osteocalcin (OC), by Overall Drug Exposure
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.
Time frame: Baseline and wk 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in Osteocalcin (OC), by Overall Drug Exposure | 1.12 mcg*wks/L |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in Osteocalcin (OC), by Overall Drug Exposure | -0.10 mcg*wks/L |
p-value: 0.1172Wilcoxon (Mann-Whitney)
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in PTH, by Overall Drug Exposure
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.
Time frame: Baseline and wk 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in PTH, by Overall Drug Exposure | -0.09 pg*wks/mL |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in PTH, by Overall Drug Exposure | 3.59 pg*wks/mL |
p-value: 0.4043Wilcoxon (Mann-Whitney)
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in SCr, by Overall Drug Exposure
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.
Time frame: Baseline and wk 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in SCr, by Overall Drug Exposure | 0.01 mg*wks/dL |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in SCr, by Overall Drug Exposure | -0.02 mg*wks/dL |
p-value: 0.7785Wilcoxon (Mann-Whitney)
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in TRP, by Overall Drug Exposure
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.
Time frame: Baseline and wk 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in TRP, by Overall Drug Exposure | 0.03 % of phosphorus reabsorbed*wks |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in TRP, by Overall Drug Exposure | -1.28 % of phosphorus reabsorbed*wks |
p-value: 0.5491Wilcoxon (Mann-Whitney)
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UB2MG, by Overall Drug Exposure
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.
Time frame: Baseline and wk 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UB2MG, by Overall Drug Exposure | -0.21 ng*wks/mL |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UB2MG, by Overall Drug Exposure | -79.82 ng*wks/mL |
p-value: 0.0719Wilcoxon (Mann-Whitney)
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UCa/UCr Ratio, by Overall Drug Exposure
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.
Time frame: Baseline and wk 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UCa/UCr Ratio, by Overall Drug Exposure | 0.00 ratio*weeks |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UCa/UCr Ratio, by Overall Drug Exposure | 0.00 ratio*weeks |
p-value: 0.599Wilcoxon (Mann-Whitney)
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UGluc, by Overall Drug Exposure
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.
Time frame: Baseline and wk 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UGluc, by Overall Drug Exposure | -0.01 mg*wks/dL |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UGluc, by Overall Drug Exposure | 0.02 mg*wks/dL |
p-value: 0.139Wilcoxon (Mann-Whitney)
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in URBP/UCr Ratio, by Overall Drug Exposure
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.
Time frame: Baseline and wk 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in URBP/UCr Ratio, by Overall Drug Exposure | -710.86 mcg*wks/g |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in URBP/UCr Ratio, by Overall Drug Exposure | 1606.38 mcg*wks/g |
p-value: 0.537Wilcoxon (Mann-Whitney)
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Femoral Neck BMD, by Overall Drug Exposure
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.
Time frame: Baseline and wk 24
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Femoral Neck BMD, by Overall Drug Exposure | -0.80 % change*wks |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Femoral Neck BMD, by Overall Drug Exposure | 0.62 % change*wks |
p-value: 0.0148Wilcoxon (Mann-Whitney)
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Lumbar Spine BMD, by Overall Drug Exposure
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.
Time frame: Baseline and wk 24
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Lumbar Spine BMD, by Overall Drug Exposure | -0.33 % change*wks |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Lumbar Spine BMD, by Overall Drug Exposure | 0.00 % change*wks |
p-value: 0.2926Wilcoxon (Mann-Whitney)
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Total Body BMC, by Overall Drug Exposure
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.
Time frame: Baseline and wk 24
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Total Body BMC, by Overall Drug Exposure | -0.40 % change*wks |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Total Body BMC, by Overall Drug Exposure | -0.24 % change*wks |
p-value: 0.4154Wilcoxon (Mann-Whitney)
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Femoral Neck BMD, by Overall Drug Exposure
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.
Time frame: Baseline and wk 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Femoral Neck BMD, by Overall Drug Exposure | -1.89 % change*wks |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Femoral Neck BMD, by Overall Drug Exposure | 1.14 % change*wks |
p-value: 0.0166Wilcoxon (Mann-Whitney)
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Lumbar Spine BMD, by Overall Drug Exposure
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.
Time frame: Baseline and wk 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Lumbar Spine BMD, by Overall Drug Exposure | -0.32 % change*wks |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Lumbar Spine BMD, by Overall Drug Exposure | 0.88 % change*wks |
p-value: 0.1906Wilcoxon (Mann-Whitney)
Secondary
Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Total Body BMC, by Overall Drug Exposure
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.
Time frame: Baseline and wk 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Total Body BMC, by Overall Drug Exposure | -0.60 % change*wks |
| Low Exposure Group | Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Total Body BMC, by Overall Drug Exposure | -1.24 % change*wks |
p-value: 0.7125Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline to Week 48 in Serum Calcium (SCa)
Serum calcium Week 48 difference from baseline
Time frame: Baseline and wk 48
Population: Subjects with data for baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change From Baseline to Week 48 in Serum Calcium (SCa) | -0.07 mg/dL |
p-value: 0.6545Wilcoxon Signed Rank Test
Secondary
Change From Baseline to Week 48 in Serum Phosphate (SPO4)
Serum Phosphate (SPO4) Week 48 difference from baseline
Time frame: Baseline and wk 48
Population: Subjects with data for baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change From Baseline to Week 48 in Serum Phosphate (SPO4) | 0.00 mmol/L |
Secondary
Change From Baseline to Week 48 in Urine Calcium (UCa) / Urine Creatinine (UCr)
Urine Calcium (UCa) / Urine Creatinine (UCr) ratio Week 48 difference from baseline
Time frame: Baseline and wk 48
Population: Subjects with data for baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change From Baseline to Week 48 in Urine Calcium (UCa) / Urine Creatinine (UCr) | 0.00 ratio |
p-value: 0.8739Wilcoxon Signed Rank Test
Secondary
Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Serum Creatinine (SCr)
SCr Week 48 difference from baseline
Time frame: Baseline and wk 48
Population: Subjects with data for baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Serum Creatinine (SCr) | -0.01 mg/dL |
p-value: 0.7986Wilcoxon Signed Rank Test
Secondary
Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Beta-2 Microglobulin (UB2MG)
UB2MG Week 48 difference from baseline
Time frame: Baseline and wk 48
Population: Subjects with data for baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Beta-2 Microglobulin (UB2MG) | -34.78 ng/mL |
p-value: 0.2431Wilcoxon Signed Rank Test
Secondary
Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Glucose (UGluc)
UGluc Week 48 difference from baseline
Time frame: Baseline and wk 48
Population: Subjects with data for baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Glucose (UGluc) | -0.01 mg/dL |
p-value: 0.5379Wilcoxon Signed Rank Test
Secondary
Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Protein (UProt) / Urine Creatinine (UCr)
UProt/ UCr Week 48 difference from baseline
Time frame: Baseline and wk 48
Population: Subjects with data for baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Protein (UProt) / Urine Creatinine (UCr) | 0.00 ratio |
p-value: 0.7209Wilcoxon Signed Rank Test
Secondary
Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)
URBP/UCr Week 48 difference from baseline
Time frame: Baseline and wk 48
Population: Subjects with data for baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr) | -601.14 mcg/g |
p-value: 0.5014Wilcoxon Signed Rank Test
Secondary
Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Serum Creatinine (SCr)
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).
Time frame: Baseline and wk 48
Population: Subjects with data for baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Serum Creatinine (SCr) | 0.99 fold change |
Secondary
Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Beta-2 Microglobulin (UB2MG)
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).
Time frame: Baseline and wk 48
Population: Subjects with data for baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Beta-2 Microglobulin (UB2MG) | 0.72 fold change |
Secondary
Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Glucose (UGluc)
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).
Time frame: Baseline and wk 48
Population: Subjects with data for baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Glucose (UGluc) | 0.94 fold change |
Secondary
Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Protein (UProt)/ Urine Creatinine (UCr)
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).
Time frame: Baseline and wk 48
Population: Subjects with data for baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Protein (UProt)/ Urine Creatinine (UCr) | 1.01 fold change |
Secondary
Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)
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).
Time frame: Baseline and wk 48
Population: Subjects with data for baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr) | 0.81 fold change |
Secondary
Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in SCr
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in SCr | 1.09 fold change |
Secondary
Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UB2MG
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UB2MG | 2.59 fold change |
Secondary
Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UGluc
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UGluc | 1.56 fold change |
Secondary
Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UProt/UCr
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UProt/UCr | 1.36 fold change |
Secondary
Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr) | 1.80 fold change |
Secondary
Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in Scr
The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in Scr | 0.01 (mg/dL)/ weeks |
Secondary
Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UB2MG
The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UB2MG | 12.45 (ng/mL)/ weeks |
Secondary
Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UGluc
The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UGluc | 0.00 (mg/dL)/ weeks |
Secondary
Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UProt/UCr
The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UProt/UCr | 0.00 Weeks^-1 |
Secondary
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)
The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 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) | 270.70 (mcg/g)/ weeks |
Secondary
Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UB2MG
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UB2MG | 12.00 weeks |
Secondary
Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UGluc
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UGluc | 24.00 weeks |
Secondary
Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UProt/UCr
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UProt/UCr | 24.00 weeks |
Secondary
Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr) | 12.00 weeks |
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 Dihydroxy Vitamin D (1,25 OHD), Change From Baseline to Week 48
Time frame: Baseline and wk 48
Population: Subjects with data for baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 Dihydroxy Vitamin D (1,25 OHD), Change From Baseline to Week 48 | -8.61 pmol/L |
p-value: 0.2452Wilcoxon Signed Rank Test
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Magnitude of Fold Change
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).
Time frame: Baseline and wk 48
Population: Subjects with data for baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Magnitude of Fold Change | 0.95 fold change |
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Most Extreme Fold Change
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Most Extreme Fold Change | 1.33 fold change |
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25-OHD, Slope of the Curve of Baseline to Most Extreme Fold Change
The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25-OHD, Slope of the Curve of Baseline to Most Extreme Fold Change | 4.27 (pmol/L)/ weeks |
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Time to Most Extreme Fold Change
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Time to Most Extreme Fold Change | 12.00 weeks |
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Change From Baseline to Week 48 in C-Telopeptide (CTX)
CTX Week 48 difference from baseline
Time frame: Baseline and wk 48
Population: Subjects with data for baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Change From Baseline to Week 48 in C-Telopeptide (CTX) | 25.90 pM |
p-value: 0.3483Wilcoxon Signed Rank Test
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Change From Baseline to Week 48 in Osteocalcin (OC)
OC Week 48 difference from baseline
Time frame: Baseline and wk 48
Population: Subjects with data for baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Change From Baseline to Week 48 in Osteocalcin (OC) | 0.05 mcg/L |
p-value: 0.8507Wilcoxon Signed Rank Test
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: FGF23, Slope of the Curve of Baseline to Most Extreme Fold Change
The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: FGF23, Slope of the Curve of Baseline to Most Extreme Fold Change | 0.39 (pg/mL)/ weeks |
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Change From Baseline to Week 48
Time frame: Baseline and wk 48
Population: Subjects with data for baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Change From Baseline to Week 48 | -1.50 pg/ML |
Comparison: Test of difference at Week 48 from baselinep-value: 0.2085Wilcoxon (Mann-Whitney)
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Magnitude of Fold Change
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).
Time frame: Baseline and wk 48
Population: Subjects with data for baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Magnitude of Fold Change | 0.96 fold change |
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Most Extreme Fold Change
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Most Extreme Fold Change | 1.18 fold change |
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Time to Most Extreme Fold Change
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Time to Most Extreme Fold Change | 12.00 weeks |
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Magnitude of Fold Change
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).
Time frame: Baseline and wk 48
Population: Subjects with data for baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Magnitude of Fold Change | 1.02 fold change |
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Most Extreme Fold Change
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Most Extreme Fold Change | 1.10 fold change |
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Time to Most Extreme Fold Change
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Time to Most Extreme Fold Change | 24.00 weeks |
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Glomerular Filtration Rate (GFR), Change From Baseline to Week 48
Time frame: Baseline and wk 48
Population: Subjects with data for baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Glomerular Filtration Rate (GFR), Change From Baseline to Week 48 | 3.06 ml/min/1.73m^2 |
p-value: 0.0806Wilcoxon Signed Rank Test
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Most Extreme Fold Change in C-telopeptide (CTX)
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Most Extreme Fold Change in C-telopeptide (CTX) | 1.37 fold change |
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Most Extreme Fold Change in Osteocalcin (OC)
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Most Extreme Fold Change in Osteocalcin (OC) | 1.14 fold change |
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: OC, Time to Most Extreme Fold Change
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: OC, Time to Most Extreme Fold Change | 12.00 weeks |
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Most Extreme Fold Change
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Most Extreme Fold Change | 1.35 fold change |
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Slope of the Curve of Baseline to Most Extreme Fold Change
The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Slope of the Curve of Baseline to Most Extreme Fold Change | 0.51 (pg/mL)/ weeks |
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Time to Most Extreme Fold Change
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Time to Most Extreme Fold Change | 24.00 weeks |
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Serum Creatinine (SCr), Time to Most Extreme Fold Change
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Serum Creatinine (SCr), Time to Most Extreme Fold Change | 8.00 weeks |
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Slope of the Curve of Baseline to Most Extreme Fold Change in CTX
The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Time frame: Baseline, Weeks (wks) 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Slope of the Curve of Baseline to Most Extreme Fold Change in CTX | 17.98 (pM)/ weeks |
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Slope of the Curve of Baseline to Most Extreme Fold Change in OC
The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Slope of the Curve of Baseline to Most Extreme Fold Change in OC | 0.07 (mcg/L)/ weeks |
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Time to Most Extreme Fold Change in C-telopeptide (CTX)
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Time to Most Extreme Fold Change in C-telopeptide (CTX) | 12.00 weeks |
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Magnitude of Fold Change
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).
Time frame: Baseline and wk 48
Population: Subjects with data for baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Magnitude of Fold Change | 0.99 fold change |
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Most Extreme Fold Change
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Most Extreme Fold Change | 1.05 fold change |
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Slope of the Curve of Baseline to Most Extreme Fold Change
The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Slope of the Curve of Baseline to Most Extreme Fold Change | 0.21 (% phosphorus reabsorbed)/ weeks |
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Time to Most Extreme Fold Change
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Time to Most Extreme Fold Change | 24.00 weeks |
Secondary
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Tubular Reabsorption of Phosphate (TRP), Change From Baseline to Week 48
Time frame: Baseline and wk 48
Population: Subjects with data for baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Tubular Reabsorption of Phosphate (TRP), Change From Baseline to Week 48 | -0.57 percentage of phosphorus reabsorbed |
Secondary
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH1 From Baseline
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)
Time frame: Baseline and wk 72
Population: Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH1 From Baseline | 0.01 g/cm^2 |
Secondary
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH1 From Week 48 (or Last Visit on Study)
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)
Time frame: Wk 48 (or last available measurement on study), Wk 72
Population: Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH1 From Week 48 (or Last Visit on Study) | 0.00 g/cm^2 |
Secondary
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH2 From Baseline
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)
Time frame: Baseline and wk 96
Population: Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH2 From Baseline | 0.00 g/cm^2 |
Secondary
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH2 From Week 48 (or Last Visit on Study)
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)
Time frame: W 48 (or last available measurement on study), Wk 96
Population: Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH2 From Week 48 (or Last Visit on Study) | -0.01 g/cm^2 |
Secondary
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH1 From Baseline
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.
Time frame: Baseline and wk 72
Population: Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH1 From Baseline | 0.10 z-score |
Secondary
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH1 From Week 48 (or Last Visit on Study)
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.
Time frame: Week 48 (or last available measurement on study), Week 72
Population: Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH1 From Week 48 (or Last Visit on Study) | 0.00 z-score |
Secondary
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH2 From Baseline
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.
Time frame: Baseline, Week 96
Population: Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH2 From Baseline | 0.10 z-score |
Secondary
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH2 From Week 48 (or Last Visit on Study)
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.
Time frame: Wk 48 (or last available measurement on study), Wk 96
Population: Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH2 From Week 48 (or Last Visit on Study) | -0.05 z-score |
Secondary
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH1 From Baseline
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)
Time frame: Baseline and wk 72
Population: Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH1 From Baseline | -0.01 g/cm^2 |
Secondary
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH1 From Week 48 (or Last Visit on Study)
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)
Time frame: Wk 48 (or last available measurement on study), Wk 72
Population: Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH1 From Week 48 (or Last Visit on Study) | -0.01 g/cm^2 |
Secondary
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH2 From Baseline
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)
Time frame: Baseline and wk 96
Population: Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH2 From Baseline | -0.01 g/cm^2 |
Secondary
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH2 From Week 48 (or Last Visit on Study)
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)
Time frame: Wk 48 (or last available measurement on study), Wk 96
Population: Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH2 From Week 48 (or Last Visit on Study) | -0.01 g/cm^2 |
Secondary
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH1 From Baseline
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.
Time frame: Baseline and wk 72
Population: Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH1 From Baseline | 0.10 z-score |
Secondary
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH1 From Week 48 (or Last Visit on Study)
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.
Time frame: Wk 48 (or last available measurement on study), Wk 72
Population: Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH1 From Week 48 (or Last Visit on Study) | 0.00 z-score |
Secondary
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH2 From Baseline
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.
Time frame: Baseline and wk 96
Population: Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH2 From Baseline | 0.20 z-score |
Secondary
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH2 From Week 48 (or Last Visit on Study)
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.
Time frame: Wk 48 (or last available measurement on study), Wk 96
Population: Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH2 From Week 48 (or Last Visit on Study) | 0.00 z-score |
Secondary
Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH1 From Baseline
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)
Time frame: Baseline and wk 72
Population: Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH1 From Baseline | 7.90 g |
Secondary
Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH1 From Week 48 (or Last Visit on Study)
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)
Time frame: Wk 48 (or last available measurement on study), Wk 72
Population: Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH1 From Week 48 (or Last Visit on Study) | -27.80 g |
Secondary
Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH2 From Baseline
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)
Time frame: Baseline and wk 96
Population: Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH2 From Baseline | -17.49 g |
Secondary
Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH2 From Week 48 (or Last Visit on Study)
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)
Time frame: Wk 48 (or last available measurement on study), Wk 96
Population: Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH2 From Week 48 (or Last Visit on Study) | -46.83 g |
Secondary
Magnitude of Change in Femoral Neck BMD at Week 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).
Time frame: Baseline and wk 48
Population: Subjects with data for Baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Magnitude of Change in Femoral Neck BMD at Week 48 | 1.00 fold change |
Secondary
Magnitude of Change in Femoral Neck BMD Z-score at Week 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).
Time frame: Baseline and wk 48
Population: Subjects with data for Baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Magnitude of Change in Femoral Neck BMD Z-score at Week 48 | 1.00 fold change |
Secondary
Magnitude of Change in Lumbar Spine BMD at Week 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).
Time frame: Baseline and wk 48
Population: Subjects with data for Baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Magnitude of Change in Lumbar Spine BMD at Week 48 | 1.00 fold change |
Secondary
Magnitude of Change in Lumbar Spine BMD Z-score at Week 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.
Time frame: Baseline and wk 48
Population: Subjects with data for Baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Magnitude of Change in Lumbar Spine BMD Z-score at Week 48 | 1.04 fold change |
Secondary
Magnitude of Change in Total Body BMC at Week 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).
Time frame: Baseline and wk 48
Population: Subjects with data for Baseline and Week 48
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Magnitude of Change in Total Body BMC at Week 48 | 1.00 fold change |
Secondary
Magnitude of Most Extreme Fold Change: Serum Calcium (SCa)
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with data available for at least two time points
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Magnitude of Most Extreme Fold Change: Serum Calcium (SCa) | 1.03 fold change |
Secondary
Magnitude of Most Extreme Fold Change: SPO4
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Magnitude of Most Extreme Fold Change: SPO4 | 1.14 fold change |
Secondary
Magnitude of Most Extreme Fold Change: UCa/UCr Ratio
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Magnitude of Most Extreme Fold Change: UCa/UCr Ratio | 1.95 fold change |
Secondary
Slope of the Curve of Baseline to Most Extreme Fold Change: Serum Calcium (SCa)
The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Slope of the Curve of Baseline to Most Extreme Fold Change: Serum Calcium (SCa) | 0.02 (mg/dL)/ weeks |
Secondary
Slope of the Curve of Baseline to Most Extreme Fold Change: SPO4
The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Slope of the Curve of Baseline to Most Extreme Fold Change: SPO4 | 0.01 (mmol/L)/ weeks |
Secondary
Slope of the Curve of Baseline to Most Extreme Fold Change: UCa/UCr Ratio
The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Slope of the Curve of Baseline to Most Extreme Fold Change: UCa/UCr Ratio | 0.00 (mg/mg)/ weeks |
Secondary
Time to Most Extreme Fold Change: Serum Calcium (SCa)
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Time to Most Extreme Fold Change: Serum Calcium (SCa) | 12.00 weeks |
Secondary
Time to Most Extreme Fold Change: SPO4
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Time to Most Extreme Fold Change: SPO4 | 12.00 weeks |
Secondary
Time to Most Extreme Fold Change: UCa/UCr Ratio
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: Subjects with at least two measurements available for comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | Time to Most Extreme Fold Change: UCa/UCr Ratio | 12.00 weeks |