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Trial · NCT00051558

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)18 month endpointThe intention-to-treat analysis was performed using all randomized and treated patients.grams per square centimetersLEAST_SQUARES_MEAN
SECONDARYChange From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset18 month endpointThe intention-to-treat analysis was performed using all randomized and treated patients (female only subset).grams per square centimetersLEAST_SQUARES_MEAN
SECONDARYTime Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined3, 6, 12, 18, 24, 36 monthsThe intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed.grams per square centimetersLEAST_SQUARES_MEAN
SECONDARYTime Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset3, 6, 12, and 18 monthsThe intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed.grams per square centimetersLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined24 and 36 months and Endpoint at 36 months
The intention-to-treat analysis was performed using all randomized and treated patients. For 24 and 36 month time points, no missing data were imputed. However, at the 36 month endpoint, last observation carried forward analysis was applied.
grams per square centimetersLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined18, 24, 36 months, and 18 and 36 month endpoints
The intention-to-treat analysis was performed using all randomized and treated patients. For 18, 24 and 36 month time points, no missing data were imputed. However at the 36 month endpoint, last observation carried forward analysis was applied.
grams per square centimetersLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined18, 24, 36 months, and 18 and 36 month endpoints
The intention-to-treat analysis was performed using all randomized and treated patients. For 18, 24 and 36 month time points, no missing data were imputed. However, at 18 and 36 month endpoints, last observation carried forward analyses were applied.
grams per square centimetersLEAST_SQUARES_MEAN
SECONDARYTime Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined12, 18, 24, and 36 monthsThe intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed.grams per square centimetersLEAST_SQUARES_MEAN
SECONDARYTime Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined12, 18, 24, and 36 monthsThe intention-to-treat analysis was performed using all randomized and treated patients. No missing data was imputed.grams per square centimetersLEAST_SQUARES_MEAN
SECONDARYTime Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen1, 6, 18, and 36 monthsSubset of patients with measures of biochemical markerspercentMEAN
SECONDARYTime Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen1, 6, 18, and 36 monthsSubset of patients with measures of biochemical markers.percentMEAN
SECONDARYTime Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase1, 6, 18, and 36 monthsSubset of patients with measures of biochemical markerspercentMEAN
SECONDARYTime Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments1, 6, 18, and 36 monthsSubset of patients with measures of biochemical markerspercentMEAN
SECONDARYTime Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin1, 6, 18, and 36 monthsSubset of patients with measures of biochemical markerspercentMEAN
SECONDARYAny Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures36 monthsFor vertebral fractures, only those patients with baseline and postbaseline spinal radiographs were included in the analysis.participantsNUMBER

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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