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Effect of Calcium and Vitamin D on Bone Loss From the Hip

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Tufts University

Status and phase

Completed
Phase 3

Conditions

Osteoporosis

Treatments

Drug: Calcium 500 mg/day and vitamin D 700 IU/day

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00357643
U01AG010353

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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