Trial · NCT01011556
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months | Baseline, 12 Months | Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model and least square (LS) means were adjusted for baseline BMD values as a covariate and pooled site and treatment as fixed effects. |
| Secondary | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months | Baseline, 6 Months | Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects. |
| Secondary | Time Course Change of BMD Response at the Lumbar Spine | Baseline to 6 Months and 12 Months | To assess the time course of the treatment, the BMD data of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA) and analyzed using a mixed model repeated measures (MMRM) method, with the repeated measure occurring at each visit (for example, 6 and 12 month). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). |
| Secondary | Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) | Baseline, 1 Month, 3 Months, 6 Months, 12 Months | Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation. |
| Secondary | Percent Change From Baseline of C-Terminal Telopeptide (CTX) | Baseline, 1 Month, 3 Months, 6 Months, 12 Months | C-terminal telopeptide is a marker of bone resorption. |
| Secondary | Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month | Baseline, 1 Month | Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation. |
| Secondary | Convenience/Ease of Use Questionnaire (CEUQ) | baseline up to 12 months | CEUQ consists of 5 sections and 16 questions using a 5-point Likert scale designed to collect measures for ease of use (S1), convenience of use (S2), confidence of use (S3), fear of use (S4), and overall satisfaction with therapy (S5). CEUQ is not a validated instrument. |
| Secondary | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | Baseline, 12 Months | Serum calcium adjusted for serum albumin levels is calculated using the following formula: Total Calcium + \[(40 - albumin) x 0.02\]. Analysis for serum calcium and albumin adjusted serum calcium were collected at predose, 4 hours (h) post-dose (PD) and 6 h PD at baseline and 12 months (mon). |
| Secondary | Change From Baseline in Urine Calcium Excretion at 6 and 12 Months | Baseline, 6 Months, 12 Months | |
| 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 | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) measured at pre-dose and 30 minutes (min) and 2 hours (hr) post-dose in both the supine and standing position. |
| 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 | |
| Secondary | Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels | Baseline and 1, 3, 12, and 13 Months (mon) | Participants were tested for anti-recombinant teriparatide and anti-synthetic teriparatide titers. Either none were detected (ND) or antibodies were determined to be present if the teriparatide specific antibody titers were at least 1:8 (titer 1:8). |
| Secondary | Pharmacokinetics Parameters: Area Under the Curve (AUC) | Baseline, 1 Month, 3 Months, and 12 Months | Due to high intra-subject variability, data was not analyzed for this outcome measure. |
| Secondary | Pharmacokinetics Parameters: Maximal Concentration (Cmax) | Baseline, 1 Month, 3 Months, 12 Months | Due to high intra-subject variability, data was not analyzed for this outcome measure. |
| Secondary | DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up | 13 Month follow-up | Severity of edema was categorized based on a 5 point scale: 0=no edema, 4=severe edema (defined as an area raised more than 1 millimeter and extending beyond area of exposure) |
| Secondary | DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up | 13 Month follow-up | Severity of erythema was categorized based on a 5 point scale: 0=no erythema, 4=severe erythema (defined as beet red to eschar) |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01011556/registered