Status:
COMPLETED
Effect of Calcium and Vitamin D on Bone Loss From the Hip
Lead Sponsor:
Tufts University
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Osteoporosis
Eligibility:
All Genders
65+ years
Phase:
PHASE3
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.
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 dail...
Eligibility Criteria
Inclusion
- \>65 years calcium intake \< 1500 mg/day Willing to discontinue calcium and vitamin D pills for 2 months prior to enrollment
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 1992
Trial Type :
INTERVENTIONAL
End Date :
February 1 1996
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00357643
Start Date
October 1 1992
End Date
February 1 1996
Last Update
July 27 2006
Active Locations (1)
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1
Human Nutrition Research Center on Aging at Tufts U
Boston, Massachusetts, United States, 02111