Our central hypothesis is that impaired calcium (Ca) absorptions a major cause of bone loss in elderly women and that this can be eliminated by supplementation of Ca intake. This hypothesis is supported by our recent research studies a) describing the interrelationships among age, Ca absorption serum intact PTH, serum 1,25-dihydroxyvitamin D concentrations, and indices of bone turnover and b) showing that administration of supplementary Ca at 1.5 g/day prevented further bone loss from the lumbar spine and proximal femur in untreated patients with involutional osteoporosis. We will test this hypothesis by carrying out a 4-year prospective double-blind clinical trial of Ca supplementation in aging normal women. Our primary study objective is to determine if Ca supplementation is effective in reducing or preventing their bone loss; our secondary study objectives are to determine if parathyroid gland function and bone turnover (which are increased in older women) are reduced to the level found in normal, young adult women and to assess side effects and patient acceptability of the regimen. 240 normal women residing in Rochester, MN, who are 61 to 70 years old and at least 10 years postmenopausal, will be randomized into treatment and control limbs; the subjects in the treatment limb will receive a matching placebo. Subjects will be evaluated at baseline and every 6 months during treatment by assessment of therapeutic compliance, measurement of bone density (lumbar spine, proximal femur, and whole skeleton), biochemical markers of bone turnover (serum bone Gla-protein, bone alkaline phosphatase, and urinary cAMP), and parathyroid gland function (serum intact PTH and urinary cAMP). Given the enormous magnitude of the problem of involutional osteoporosis, the only cost-effective approach is prevention. For example, the average woman, aged 65 years, will lose about 25% of the remaining bone from her proximal femur over the next 20 years. If we find that Ca supplementation effectively prevents further bone loss in elderly women (as is suggested by our preliminary data), this would reduce the incidence of subsequent hip fracture by about 50%. If these data are applied to the entire American population of elderly women, there would be annual savings of billions of dollars in health care costs. Thus, if our clinical trial can establish this relationship, an enormous step forward will have been made in controlling this major public health problem.
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