Osteoporosis
Conditions
Keywords
calcium, vitamin D, bone loss
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 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.
Interventions
DRUGCalcium 500 mg/day and vitamin D 700 IU/day
Sponsors
National Institutes of Health (NIH)
Tufts University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone Density of the hip | — |
Secondary
| Measure | Time frame |
|---|---|
| Examine influence of clinical status, lifestyle, medication use and season on the occurrence of falls | — |
| Annual and Seasonal patterns of change in bone mineral density of the hip | — |
| Associations between biochemical, physical and life-style factors | — |
Countries
United States
Outcome results
None listed