Low doses of estradiol in combination with gestodene to prevent early postmenopausal bone loss

Objective: Our purpose was to study combinations of estradiol and gestodene for prevention of bone loss in early postmenopausal women. Study Design: We randomly assigned 278 healthy, early postmenopausal women to receive either 2 mg 17β-estradiol sequentially combined with 25 μg gestodene (group 2/25s), 2 mg estradiol sequentially combined with 50 μg gestodene (group 2/50s), 1 mg estradiol sequentially combined with 25 μg gestodene (group 1/25s), 1 mg estradiol continuously combined with 25 mg gestodene (group 1/25c), or placebo. Results: After 3 years the changes in bone mineral density of the spine were as follows (mean ± SEM): group 2/25s, 7.41% ± 0.72%; group 2/50s, 8.53% ± 0.90%; group 1.25s, 6.67% ± 0.88%; group 1/25c, 4.44% ± 0.59%; and placebo group, –2.03% ± 0.64%. The changes in bone mineral density were mirrored in the biochemical bone markers. The average responses for the urinary C-terminal telopeptide fragments of type I collagen corrected for creatinine excretion were as follows (mean of baseline ± SEM): group 2/25s, –68.8% ± 0.03%; group 2/50s, –72.8% ± 0.02%; group 1/25s, –60.7% ± 0.03%; group 1/25c, –52.28% ± 0.04%; and placebo group, 6.5% ± 0.09%. Beneficial lipid effects were found in all active groups. The decreases in low-density lipoprotein were as follows (mean ± SEM): group 2/25s, –13.7% ± 3.0%; group 2/50s, –14.6% ± 3.2%; group 1/25s, –9.28% ± 2.2%; group 1/25c, –9.92% ± 2.4%; and placebo group, 1.53% ± 1.9%. Conclusion: These results demonstrate that estradiol therapy with 1 mg estradiol is fully protective against early postmenopausal bone loss. (Am J Obstet Gynecol 2000;183:550-60.)