Effect of Calcium and Vitamin D on Bone Loss From the Hip
| Tracking Information | |||||
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| First Received Date ICMJE | July 26, 2006 | ||||
| Last Updated Date | July 26, 2006 | ||||
| Start Date ICMJE | October 1992 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Bone Density of the hip | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Calcium and Vitamin D on Bone Loss From the Hip | ||||
| Official Title ICMJE | Effect of Calcium and Vitamin D on Bone Loss From the Hip | ||||
| Brief Summary | The primary aim of this study is to determine the effects of supplementation with both calcium and vitamin D on changes in bone density of the hip in men and women age 65 and older. |
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| Detailed Description | In this study 445 men and women age 65 and older were enrolled for three years each. Subjects were randomized to treatment with 500 mg of calcium s calcium citrate malate plus 700 IU of vitamin D daily or placebo. Subjects came to the research center every six months for biochemical and bone mineral density measurements. Changes in these measures over the three years were determined in each group and compared. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
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| Condition ICMJE | Osteoporosis | ||||
| Intervention ICMJE | Drug: Calcium 500 mg/day and vitamin D 700 IU/day | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 450 | ||||
| Completion Date | February 1996 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: >65 years calcium intake < 1500 mg/day Willing to discontinue calcium and vitamin D pills for 2 months prior to enrollment Exclusion Criteria: Mentally incompetent, femoral neck BMD greater than 2 SD above/below age/sex-matched reference mean, 24-hr urine calcium/creatinine > 300 mg/d women or >350 mg/d men terminal illness, renal disease requiring treatment, kidney stone in the past 10 years, current hyperparathyroidism, treated with glucocorticoids, estrogen or androgen, fluoride, calcitonin, bisphosphonate, or any other treatment for osteoporosis. |
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| Gender | Both | ||||
| Ages | 65 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00357643 | ||||
| Other Study ID Numbers ICMJE | U01AG010353 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Tufts University | ||||
| Collaborators ICMJE | National Institutes of Health (NIH) | ||||
| Investigators ICMJE |
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| Information Provided By | Tufts University | ||||
| Verification Date | June 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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