Trial · NCT00523341
Outcomes48
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 48
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) | 84 months | All participants who received at least one dose of denosumab. | participants | NUMBER |
| PRIMARY | Number of Participants With Laboratory Toxicities of Grade ≥ 3 | 84 months | All participants who received at least 1 dose of denosumab | participants | NUMBER |
| PRIMARY | Number of Participants With Antibodies to Denosumab | Every 12 months through Month 84 | All participants who received at least 1 dose of denosumab | participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Lumbar Spine Bone Mineral Density by Visit | Baseline (of extension study) and months 12, 24, 36, 60 and 84 | Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Hip Bone Mineral Density by Visit | Baseline (of extension study) and months 12, 24, 36, 60 and 84 | Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Femoral Neck Bone Mineral Density by Visit | Baseline (of extension study) and months 12, 24, 36, 60 and 84 | Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in 1/3 Radius Bone Mineral Density by Visit | Baseline (of extension study) and months 12, 24, 36, 60 and 84 | Participants in the DXA substudy with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Study 20030216 Baseline in Lumbar Spine Bone Mineral Density by Visit | Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84 | Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Study 20030216 Baseline in Total Hip BMD by Visit | Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84 | Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Study 20030216 Baseline in Femoral Neck BMD by Visit | Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84 | Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Study 20030216 Baseline in 1/3 Radius BMD by Visit | Study 20030216 baseline and extension study months 12, 24, 36, 60, and 84 | Participants in the DXA substudy with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With New Vertebral Fractures | 84 months | All participants enrolled in the extension study who have vertebral X-ray assessment at the extension baseline and at least 1 post-extension baseline visit. | participants | NUMBER |
| SECONDARY | Number of Participants With Non-Vertebral Fractures | 84 months | All enrolled participants | participants | NUMBER |
| SECONDARY | Percent Change From Baseline in C-Telopeptide 1 (CTX-1) by Visit | Baseline (of extension study), day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84 | Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. n indicates the number of participants with available data at each time point. | percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) by Visit | Baseline (of extension study), day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84 | Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. n indicates the number of participants with available data at each time point. | percent change | MEDIAN |
| SECONDARY | Percent Change From Study 20030216 Baseline in CTX-1 by Visit | Study 20030216 Baseline and extension study day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84 | Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. n indicates the number of participants with available data at each time point. | percent change | MEDIAN |
| SECONDARY | Percent Change From Study 20030216 Baseline in P1NP by Visit | Study 20030216 Baseline and extension study day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84 | Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. n indicates the number of participants with available data at each time point. | percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Albumin-adjusted Serum Calcium at Day 10 | Baseline (of extension study) and day 10 | Participants who had a calcium corrected by albumin measurement within the Day 10 visit window up to May 31, 2008. | percent change | MEDIAN |
| SECONDARY | Serum Denosumab Concentration | Baseline (pre-dose in extension study), day 10, and Months 3, 4 and 6 (pre-dose) | Participants who participated in the Study 20030216 PK substudy, for whom dosing information was not missing and for whom sampling was within 14 days of specified sampling times. | ng/mL | MEAN |
| SECONDARY | Bone Histomorphometry: Cancellous Bone Volume | Month 24 and month 84 | Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available cancellous bone volume data. | percentage of total bone tissue volume | 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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