Trial · NCT00471237
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Bone Marrow Density (BMD) at Month 12 Measured by Dual-Energy X-Ray Absorptiometry (DXA) Scans of the Lumbar Spine (L1-L4) | Baseline (Day 0) and 12 Months | Intent-to-Treat population comprised of any randomised or teriparatide participant who received at least one dose of study medication. Only those participants available at the specified time points were analyzed. Teriparatide arm was excluded from the analysis, since these participants were not randomized and were disproportionately represented. | Percent change in BMD | LEAST_SQUARES_MEAN |
| PRIMARY | Number of Participants With Hypercalcemia | Up to Month 12 | Intent-to-Treat population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Withdrew Due to Hypercalcemia | Up to Month 12 | Intent-to-Treat population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit | Up to Month 12 | Intent-to-Treat population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit | Up to 12 Months | Intent-to-Treat population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participant With Electrocardiogram (ECG) Findings Reported as Adverse Event | Up to 12 months | Intent-to-Treat population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Mean Change From Baseline in Height | Baseline (Day 0), Month 6, 12 and early withdrawal | Intent-to-Treat population. Only those participants available at the specified time points were analyzed. | Centimeter | MEAN |
| PRIMARY | Mean Change From Baseline in Weight | Baseline (Day 0), Month 6, 12 and early withdrawal | Intent-to-Treat population. Only those participants available at the specified time points were analyzed. | Kilogram | MEAN |
| SECONDARY | Percent Change From Baseline to Month 6 in BMD Measured by DXA Scans of the Lumbar Spine (L1-L4) | Baseline (Day 0) and Month 6 | Intent to Treat Population. Only those participants available at the specified time point were analyzed. Participants from Teriparatide, 20 mcg, SC injection, OD arm were excluded from the analysis, since these participants were not randomized and were disproportionately represented. | percent change in BMD | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Months 6 and 12 in BMD Measured by DXA Scans of the Hip (Total Hip, Femoral Neck and Trochanter). | Baseline (Day 0), Month 6 and Month 12 | Intent-to-Treat population. Only those participants available at the specified time points were analyzed. Participants from Teriparatide, 20 mcg, SC injection, OD arm were excluded from the analysis, since these participants were not randomized and were disproportionately represented. | Percent change in BMD | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline) | Baseline (Day 0), Month 5, 6 and 12 | Intent-to-Treat population. Only those participants available at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans | Baseline (Day 0) and Month 12 | Intent-to-Treat population. Only those participants available at the specified time points were analyzed. | Percent change in BMD | MEAN |
| SECONDARY | Percent Change From Baseline to Month 12 in the Total Vertebra Integral VOI at the Lumbar Spine as Measured by QCT Scans | Baseline (Day 0) and Month 12 | Intent-to-Treat population. Only those participants available at the specified time points were analyzed. | Percent change in VOI | MEAN |
| SECONDARY | Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans | Baseline (Day 0) and Month 12 | Intent-to-Treat population. Only those participants available at the specified time points were analyzed. | Percent change in BMD | MEAN |
| SECONDARY | Percent Change From Baseline to Month 12 in Cortical Thickness at the Hip as Measured by QCT Scans | Baseline (Day 0) and Month 12 | Intent-to-Treat population. Only those participants available at the specified time points were analyzed. | Percent change in cortical thickness | MEAN |
| SECONDARY | Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1) | Baseline (Day 0), Week 4, Month 3, 6, and 12 | Intent-to-Treat population. Only those participants available at the specified time points were analyzed. | nanogram per litre (ng/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP) | Baseline (Day 0), Week 4, Month 3, 6, and 12 | Intent to treat population. Only those participants available at the specified time points were analyzed. | Microgram per Litre (mcg/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP) | Baseline (Day 0), Week 4, Month 3, 6, and 12 | Intent-to-Treat population. Only those participants available at the specified time points were analyzed. | mcg/L | LEAST_SQUARES_MEAN |
| SECONDARY | Blood Concentrations of Ronacaleret | Pre-dose (0.0 hour [h]) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12 | Pharmacokinetic Concentration Population comprised of any Intent-to-Treat participants for whom a SB-751689 pharmacokinetic blood sample was obtained and analyzed. Only those participants available at the specified time points were analyzed. | nanograms per millilitre (ng/mL) | MEAN |
| SECONDARY | Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret | Pre-dose (0.0 h) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12 | Pharmacokinetic Parameters Population comprised of any participant in the pharmacokinetic concentration population who provided pharmacokinetic parameters. Only those participants available at the specified time points were analyzed. | nanogram*hour per millilitre (ng*hr/mL) | GEOMETRIC_MEAN |
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.
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