Oral, water-soluble combined estrogen/calcium preparation for postmenopausal therapy

Objectives: Estrogen is often prescribed for symptoms and sequelae of ovari an estrogen loss after menopause. Methods: To assess efficacy and acceptability of a new, highly soluble estr ogen-calcium preparation, we formulated a water-soluble powdered combinatio n of estrogen (0.625 mg estrone piperazine sulfate) and calcium (1 g, ions) as the highly soluble glycerophosphate salt (Estrosol(R)). Effects of once -daily administration on bone mineral turnover of Estrosol(R) dissolved in water (n = 11) was compared with 0.625 mg conjugated estrogens (Premarin(R) ) + 1 g calcium (Tums(R) 500 Calcium Supplement) (n = 8). All women had had a previous hysterectomy, were between the ages 40 and 75, within 25% of id eal body weight, and had nut taken hormonal preparations for at least 3 mon ths. Assessment of bone mineral turnover was by monitoring N-telopeptides a nd bone specific alkaline phosphatase (BSAP) on 5 occasions: pretreatment a nd once juring each of the 4 months of treatment. Results: Mean N-telopeptide values decreased (p=.005) in both groups. Estro sol(R) 29.2% (40 --> 29 mmol bone collagen equivalents (BCE)/mmol creatinin e), and Premarin(R) + calcium, 44.8%(33 --> 18 mmol). Mean BSAP values also decreased (p = 0.007) in both groups: Estrosol(R), 12.6% (12.06 - 10.54 mg /l), Premarin(R) + calcium, 19.1% (11.57 --> 9.36 mg/l). The difference bet ween groups for both N-telopeptides and BSAP was not significant, although sample size was small. Symptoms (hot Rashes, vaginal dryness) improved simi larly in both groups. Symptoms during treatment (breast or nipple tenderness, bloating) also were similar in both groups. Both preparations were well-tolerated. There were no changes in CBC, liver function tests? electrolytes or urinalyses in eith er group. Conclusions: This pilot study indicates that the combined, highly water-sol uble preparation of estrogen and calcium is effective in reducing bone mine ral turnover, acceptable and well-tolerated. Use of this single aqueous pre paration may lead to better compliance than using two separate gills. (C) 2 001 Published by Elsevier Science Ireland Ltd.