Trial · NCT01011556
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months | Baseline, 12 Months | All participants who received at least 1 dose of drug and had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using intention-to-treat (ITT) principle, last observation carried forward method and ANCOVA model. | percentage change in BMD | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months | Baseline, 6 Months | All participants who received at least 1 dose of drug and had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using intent-to-treat principal, last observation carried forward method and ANCOVA model. | percentage change in BMD | LEAST_SQUARES_MEAN |
| SECONDARY | Time Course Change of BMD Response at the Lumbar Spine | Baseline to 6 Months and 12 Months | All participants who received at least 1 dose of drug, had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using ITT principal. | percentage change in BMD | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) | Baseline, 1 Month, 3 Months, 6 Months, 12 Months | All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied. | percentage change in P1NP | MEAN |
| SECONDARY | Percent Change From Baseline of C-Terminal Telopeptide (CTX) | Baseline, 1 Month, 3 Months, 6 Months, 12 Months | All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied. | percentage change in CTX | MEAN |
| SECONDARY | Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month | Baseline, 1 Month | All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied. | percentage change in P1CP | MEDIAN |
| SECONDARY | Convenience/Ease of Use Questionnaire (CEUQ) | baseline up to 12 months | All randomized participants who received at least 1 dose of study drug and had CEUQ assessment. Last observation was carried forward, unless the last observation was also the first completed questionnaire. | participants | NUMBER |
| SECONDARY | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | Baseline, 12 Months | All randomized participants who received at least 1 dose of study drug and had serum calcium measurements or adjusted serum calcium measurements at the indicated timepoint. | millimole/Liter (mmol/L) | MEAN |
| SECONDARY | Change From Baseline in Urine Calcium Excretion at 6 and 12 Months | Baseline, 6 Months, 12 Months | All randomized participants who received at least 1 dose of study drug and had urine calcium measurements at the indicated timepoint. | millimole/day (mmol/day) | MEAN |
| SECONDARY | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | Pre-Dose, 30 minutes, 2 hours Post-Dose at Baseline and 12 Months | All randomized participants who received at least 1 dose of study drug and had predose and postdose blood pressure measurements at the indicated timepoint and body position. | mmHg | MEAN |
| SECONDARY | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | Pre-dose, 30 minutes, 2 hours at Baseline and 12 Months | All randomized participants who received at least 1 dose of study drug and had predose and postdose heart rate measurements at the indicated timepoint and body position. | beats per minute (bpm) | MEAN |
| SECONDARY | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | Baseline and 1, 3, 12, and 13 Months (mon) | All randomized participants who received at least one dose of study drug and had antibody results. | participants | NUMBER |
| SECONDARY | Pharmacokinetics Parameters: Area Under the Curve (AUC) | Baseline, 1 Month, 3 Months, and 12 Months | Due to high intra-subject variability, zero participants were analyzed on this outcome measure. | ||
| SECONDARY | Pharmacokinetics Parameters: Maximal Concentration (Cmax) | Baseline, 1 Month, 3 Months, 12 Months | Due to high intra-subject variability, zero participants were analyzed for this outcome measure. | ||
| SECONDARY | DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up | 13 Month follow-up | All randomized participants who received at least 1 dose of study drug and had edema measurements at 13 months. | participants | NUMBER |
| SECONDARY | DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up | 13 Month follow-up | All randomized participants who received at least 1 dose of study drug and had erythema measurements at 13 months. | participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01011556/outcomes