Trial · NCT00205777
Registered outcomes60
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 60
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With New Vertebral Fractures Through Month 36 | Baseline through Month 36 | New vertebral fracture: decrease in anterior, mid, or posterior vertebral (vt) height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture. |
| Primary | Percentage of Participants With New Vertebral Fractures Through Month 60 | Baseline through Month 60 | New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture. |
| Primary | Percentage of Participants With New Vertebral Fractures Through Month 84 | Baseline through Month 84 | New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture. |
| Secondary | Incidence of Breast Cancer Through Month 36 | Baseline through Month 36 | Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time). |
| Secondary | Incidence of Breast Cancer Through Month 60 | Baseline through Month 60 | Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time). |
| Secondary | Incidence of Breast Cancer Through Month 84 | Baseline through Month 84 | Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time). |
| Secondary | Percentage of Participants With New Clinical Vertebral Fractures Through Month 36 | Baseline through Month 36 | A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base. |
| Secondary | Percentage of Participants With New Clinical Vertebral Fractures Through Month 60 | Baseline through Month 60 | A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base. |
| Secondary | Percentage of Participants With New Clinical Vertebral Fractures Through Month 84 | Baseline through Month 84 | A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base. |
| Secondary | Number of Participants With Worsening Vertebral Fractures Through Month 36 | Baseline through Month 36 | A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline. |
| Secondary | Number of Participants With Worsening Vertebral Fractures Through Month 60 | Baseline through Month 60 | A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline. |
| Secondary | Number of Participants With Worsening Vertebral Fractures Through Month 84 | Baseline through Month 84 | A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline. |
| Secondary | Percentage of Participants With Non-vertebral Fractures Through Month 36 | Baseline through Month 36 | Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized. |
| Secondary | Percentage of Participants With Non-vertebral Fractures Through Month 60 | Baseline through Month 60 | Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized. |
| Secondary | Percentage of Participants With Non-vertebral Fractures Through Month 84 | Baseline through Month 84 | Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized. |
| Secondary | Change From Baseline in Height at Month 36 | Baseline, Month 36 | Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded). |
| Secondary | Change From Baseline in Height at Month 60 | Baseline, Month 60 | Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded). |
| Secondary | Change From Baseline in Height at Month 84 | Baseline, Month 84 | Height (cm) was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded). |
| Secondary | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Baseline, Months 6, 12, 18, 24, 36 | BMD of lumbar spine (Lu Sp) and hip (total hip \[Tl Hp\], femoral neck \[Fe Ne\] and femur trochanter \[Fe Tr\]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher. |
| Secondary | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Baseline, Month 48, 60 | BMD of lumbar spine (Lu Sp) and hip (total hip \[Tl Hp\], femoral neck \[Fe Ne\] and femur trochanter \[Fe Tr\]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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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