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.
PIP: Org OD 14, a synthetic steroid with an unusual endocrine profile (weak progestational, weak estrogenic, very weak androgenic, and clear anabolic activity), was tested in a double-blind trial of 100 postmenopausal women to assess its efficacy as treatment for osteoporosis associated with menopause. This agent should reduce incidence of postmenopausal vascular disease and be free of the side effects of prolonged estrogen treatment (endometrial hyperplasia and carcinoma). Of the 100 women studied, 63 completed 2 years of treatment (33 on Org OD 14, and 30 on placebo). 2.5 mg/day was administered, and this dose successfully prevented bone loss over 2 years; on the other hand, a significant reduction in bone mineral content occurred in those women taking placebo. The difference was statistically significant (P .01). At this dosage, Org OD 14 also significantly reduced the severity of menopausal complaints, including flushing and sweating. Vabra aspiration curettage in 20 cases 6-18 months after starting active treatment showed no evidence of endometial hyperlasia, although weak proliferation of the endometrium was apparent in 3 cases. Org OD 14 does not seem to produce extensive endometrial stimulation; therefore, the potential of this agent in osteoporosis and other postclimacteric complaints warrants further investigation.