Trial · NCT00172172
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluate subjects treated with ALX1-11 (no calcium supplementation) increase in BMD is less than those treated with ALX1-11 (receiving calcium supplementation). | 6 months | |
| Primary | Primary efficacy variable is the percentage change from baseline of lumbar vertebral BMDmeasured by DXA. | 6 months | |
| Secondary | BMC, | 6 months | |
| Secondary | vBMD, | 6 months | |
| Secondary | the incidence of clinical fractures, | 6 months | |
| Secondary | height, | 6 months | |
| Secondary | biochemical markers of bone turnover for subjects treated with ALX1-11 and receiving no calcium versus those receiving ALX1-11 with calcium supplementation. | 6 months | |
| Secondary | Adverse Events | 6 months | |
| Secondary | 12 lead ECG changes | 6 months | |
| Secondary | Percentage change from baseline of lumbar vertebral BMC | 6 months | |
| Secondary | Percentage change from baseline of total hip BMD and BMC | 6 months | |
| Secondary | Percentage change from baseline in biochemical markers of bone turnover: 1) Bone formation: Serum BSAP and P1NP 2) Bone resorption: Serum CTx, urinary NTx | 6 months | |
| Secondary | Incidence of new and/or worsened vertebral (thoracic and lumbar) fractures | 6 months | |
| Secondary | Incidence of any clinical fractures (vertebral and/or non-vertebral) | 6 months | |
| Secondary | Incidence of hip fractures | 6 months | |
| Secondary | Incidence of clinical fractures other than hip, or thoracic or lumbar vertebrae | 6 months | |
| Secondary | Percentage change from baseline of trabecular volumetric BMD of spine as assessed by QCT (sub-study) | 6 months | |
| Secondary | Percentage change from baseline of trabecular volumetric BMD of hip as assessed by QCT (sub-study) | 6 months |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT00172172/registered