Osteoporosis results in bone fractures in about 50% of postmenopausal women and is a leading cause of disability in an aging population. Current therapies include an adequate calcium and vitamin D intake as well as specific treatment with compounds such as estrogens, calcitonin and the bisphosphonates.sup.(1). However, each of these treatments has either troubling side effects or limited efficacy. Women fear the small increase in breast cancer due to estrogens despite the dramatic reduction in myocardial infarctions and reduction in bone resorption. Calcitonin has a limited effect and is a protein and therefore needs to be injected or inhaled which is inconvenient. The new bisphosphonates such as alendronate have had encouraging results with an increase in bone density and decrease in fractures with few side effects. Current research for new compounds has concentrated on the systemic administration of bone anabolic compounds such as parathyroid hormone (PTH) or fragments of PTH or locally acting cytokines or bone growth factors such as bone morphogenic proteins. The appeal of PTH is that there are specific PTH receptors in bone.sup.(2) and it is well established in both experimental animal.sup.(3) and patient studies that intermittent doses of injected PTH is the most effective agent known to increase bone formation and bone strength.sup.(4-6). This effect is additive to that of estrogens. The problem with the administration of PTH is that it is a peptide and must therefore be given by injection. Women with osteoporosis have intact but inadequately functioning parathyroids and an alternative approach is to stimulate their own parathyroids to synthesize and secrete more PTH. It has been evidenced in experimental animals that this is eminently practicable and this is the basis of this present patent application.
Postmenopausal osteoporotic women do not have the appropriate increase in nocturnal serum PTH levels. In osteoporotic women, careful and repeated measurements of serum PTH, and analysis by time series prediction of plasma hormone concentration has shown that there are differences in the predictability of parathyroid hormone secretion between postmenopausal osteoporotic patients and postmenopausal non-osteoporotic controls.sup.(7).