Research Article

Prospective double-blind trial of synthetic steroid (Org OD 14) for preventing postmenopausal osteoporosis.

BMJ 1980; 280 doi: http://dx.doi.org/10.1136/bmj.280.6225.1207 (Published 17 May 1980) Cite this as: BMJ 1980;280:1207
  1. R Lindsay,
  2. D M Hart,
  3. A Kraszewski

    Abstract

    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.