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Two New Combinations of Estrogen and Progestogen for Prevention of Postmenopausal Bone Loss: Long-Term Effects on Bone, Calcium and Lipid Metabolism, Climacteric Symptoms, and Bleeding

From the Department of Clinical Chemistry, Glostrup Hospital, Glostrup, Denmark

Abstract

Bone mass, calcium and lipid metabolism, climacteric symptoms, bleeding, blood pressure, and weight changes were studied in 62 healthy postmenopausal women at 3-month intervals throughout 2 years of treatment with continuous estradiol valerate (2 mg) plus cyproterone acetate (1 mg), sequential estradiol valerate (2 mg) plus levonorgestrel (75 µg), or placebo. During the 2 years of the study, bone mineral content of the distal and ultradistal regions of the forearm (measured by single-photon absorptiometry) remained unchanged in the hormone groups, whereas bone mineral content at these sites decreased by 5 and 6%, respectively, in the placebo group. Bone mineral density in the spine (measured by dual-photon absorptiometry and dual-energy x-ray absorptiometry) increased by 3-4% in the hormone groups and decreased by 2% in the placebo group. Biochemical estimates of bone turnover (serum alkaline phosphatase and fasting urinary calcium/creatinine) decreased significantly to premenopausal levels in the hormone groups, but remained unchanged in the placebo group. Serum concentrations of total and low-density lipoprotein cholesterol were significantly reduced by 5-10% (P <.05-.01) in the estradiol + cyproterone acetate group and by 10-15% (P < .001) in the estradiol valerate + levonorgestrel group. There were no significant changes in highdensity lipoprotein cholesterol in the hormone groups. Virtually no changes were observed in the placebo group. Climacteric symptoms and hot flushes were significantly reduced in both hormone groups compared with the placebo group. Episodes of uterine bleeding occurred in all women in the estradiol valerate + levonorgestrel group, occurring regularly in 84% of the women. Two women (11%) in the estradiol valerate + cyproterone acetate group did not bleed at all; six women (32%) had more than six bleeding episodes during the 2 years. No changes in blood pressure and weight were observed. The results of this study suggest that these new estrogen and progestogen combinations adequately prevent postmenopausal bone loss and normalize bone turnover. Alterations in serum lipoproteins were compatible with decreased risk of cardiovascular disease. Both combinations provided relief from climacteric symptoms. The regimen with levonorgestrel brought bleeding under control, whereas the regimen with cyproterone acetate did not produce amenorrhea in an acceptable number of women.

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