Trial · NCT00529373
Outcomes93
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 93
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Base Study: Time From Baseline to First Morphometrically-Assessed Vertebral Fracture | Up to approximately 60 months of observation | The Full-Analysis-Set (FAS) including all randomized participants, who took at least one dose of study medication with follow-up from start of prime therapy to study termination (base study) with at least one spine radiograph on treatment (and at baseline) was used for analysis. | Parts. w/ fracture per 100 person-years | NUMBER |
| PRIMARY | Base Study: Time From Baseline to First Osteoporotic Clinical Hip Fracture (Adjudicated) | Up to approximately 60 months of observation | The FAS including all randomized participants who took at least one dose of study medication with follow-up from start of prime therapy to study termination (base study) was used for analysis. | Parts. w/ fracture per 100 person-years | NUMBER |
| PRIMARY | Base Study: Time From Baseline to First Osteoporotic Clinical Non-Vertebral Fracture (Adjudicated) | Up to approximately 60 months of observation | The FAS including all randomized participants who took at least one dose of study medication with follow-up from start of prime therapy to study termination (base study) was used for analysis. | Parts. w/ fracture per 100 person-years | NUMBER |
| PRIMARY | Base Study + First Extension: Time From Baseline to First Morphometrically-Assessed Vertebral Fracture | Up to approximately 74 months of observation | The FAS including all randomized participants, who took at least one dose of study medication with follow-up from start of prime therapy to study termination (base study + first extension-double blind period \[dbp\]) with at least one spine radiograph on treatment (and at baseline) was used for analysis. | Parts. w/ fracture per 100 person-years | NUMBER |
| PRIMARY | Base Study + First Extension: Time From Baseline to First Osteoporotic Clinical Hip Fracture (Adjudicated) | Up to approximately 74 months of observation | The FAS including all randomized participants who took at least one dose of study medication with follow-up from start of prime therapy to study termination (base study + first extension-dbp) was used for analysis. | Parts. w/ fracture per 100 person-years | NUMBER |
| PRIMARY | Base Study + First Extension: Time From Baseline to First Osteoporotic Clinical Non-Vertebral Fracture (Adjudicated) | Up to approximately 74 months of observation | The FAS including all randomized participants who took at least one dose of study medication with follow-up from start of prime therapy to study termination (base study + first extension-dbp) was used for analysis. | Parts. w/ fracture per 100 person-years | NUMBER |
| PRIMARY | Base Study + First Extension: Rate of Adverse Events | Up to approximately 74 months of observation | The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study + first extension). | Parts. with event per 100 person-years | NUMBER |
| PRIMARY | Base Study + First Extension: Rate of Discontinuations From Study Treatment Due to an Adverse Event | Up to approximately 74 months of observation | The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study + first extension). | Parts. with event per 100 person-years | NUMBER |
| PRIMARY | Base Study + First Extension + Second Extension: Percent Change From Baseline in Bone Mineral Density (BMD) Measurements of the Total Hip | Baseline and once yearly, up to approximately 108 months of observation | The FAS population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (total hip BMD) was used for analysis (base study + first extension-dbp + second extension). | Percent change | LEAST_SQUARES_MEAN |
| PRIMARY | Second Extension: Number of Participants Who Experienced an Adverse Event | Up to approximately 34 months of observation | The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for the analysis (second extension study). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Second Extension: Number of Participants Discontinuing Study Treatment Due to an Adverse Event | Up to approximately 34 months of observation | The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (second extension study). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Imaging Substudy PN032-Base: Percent Change From Baseline in Volumetric Bone Mineral Density (vBMD) at the Lumbar Spine Using Quantitative Computed Tomography | Baseline, Month 24 | The FAS including consisting of all randomized participants who took at least one dose of blinded study treatment and have a baseline and at least one on-treatment measurement available (lumbar spine vBMD) was used for analysis (PN032-Base). | Percent change | LEAST_SQUARES_MEAN |
| PRIMARY | Imaging Substudy PN032-Base + Extension: Percent Change From Baseline in vBMD at the Lumbar Spine Using Quantitative Computed Tomography | Baseline, Month 60 | The FAS including consisting of all randomized participants who took at least one dose of blinded study treatment and have a baseline and at least one on-treatment measurement available (lumbar spine vBMD) was used for analysis (PN032-Base + Extension). | Percent change | LEAST_SQUARES_MEAN |
| PRIMARY | Sarcopenia Substudy PN035: Change From Baseline in Appendicular Lean Body Mass (aLBM) | Baseline and once yearly up to 4 years | The FAS for change from baseline at specific time-points including all randomized participants who took at least one dose of study medication and had the necessary baseline and on-treatment measurements available (aLBM) was used for analysis (PN035). | kg | LEAST_SQUARES_MEAN |
| PRIMARY | Sarcopenia Substudy PN035: Change From Baseline in Short Physical Performance Battery (SPPB) Score | Baseline and once yearly up to 4 years | The FAS for change from baseline at specific time-points including all randomized participants who took at least one dose of study medication and had the necessary baseline and on-treatment measurements available (SPPB) was used for analysis (PN035). | Score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Sarcopenia Substudy PN035: Change From Baseline in Gait Speed | Baseline and once yearly up to 4 years. | The FAS for change from baseline at specific time-points including all randomized participants who took at least one dose of study medication and had the necessary baseline and on-treatment measurements available (gait speed) was used for analysis (PN035). | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Base Study: Rate of Adverse Events | Up to approximately 60 months of observation | The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study). | Parts. with event per 100 person-years | NUMBER |
| SECONDARY | Base Study: Rate of Discontinuation From Study Treatment Due to an Adverse Event | Up to approximately 60 months of observation | The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study). | Parts. with event per 100 person-years | NUMBER |
| SECONDARY | Base Study: Time From Baseline to First Osteoporotic Clinical Vertebral Fracture (Adjudicated) | Up to approximately 60 months of observation | The FAS including all randomized participants who took at least one dose of study medication with follow-up from start of prime therapy to study termination (base study) was used for analysis. | Parts. w/ fracture per 100 person-years | NUMBER |
| SECONDARY | Base Study: Yearly Rate of Height Loss | Up to approximately 60 months of observation | The FAS population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (height) was used for analysis (base study). | cm/year | LEAST_SQUARES_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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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