Prospective double-blind trial of synthetic steroid (Org OD 14) for preventing postmenopausal osteoporosis.
A double-blind trial of Org OD 14, a synthetic steroid with an unusual endocrine profile, was conducted on 100 postmenopausal women; of these, 63 completed two years' treatment (33 Org OD 14; 30 placebo). A dose of 2.5 mg/day successfully prevented bone loss over two years, whereas a significant reduction in bone mineral content occurred in women taking placebo, the rate being comparable to that in earlier studies (p less than 0.01). At the dosage used (2.5 mg/day) Org OD 14 also significantly reduced the severity of menopausal complaints (flushing, sweating, etc). Vabra aspiration curettage in 20 cases 6-18 months after starting active treatment showed no evidence of endometrial hyperplasia, though weak proliferation of the endometrium was seen in three. Org OD 14 may provide a new approach to hormonal prevention of bone loss in postmenopausal women without inducing appreciable endometrial stimulation; the potential value of Org OD 14 in osteoporosis and other post-climacteric complaints warrants further investigation.
D001862:Bone Resorption; D002118:Calcium / Q000378:metabolism; D002979:Climacteric; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D006728:Hormones / Q000627:therapeutic use*; D006801:Humans; D006909:Hydroxyproline / Q000652:urine; D010024:Osteoporosis / Q000517:prevention & control*; D010710:Phosphates / Q000378:metabolism
D006728:Hormones; D010710:Phosphates; D006909:Hydroxyproline; D002118:Calcium