Effect of Menopausal Hormone Therapy on Bone Mineral Density in Chinese Women: A 2-Year, Prospective, Open-Label, Randomized-Controlled Trial.

BACKGROUND This study was designed to explore the effect of menopausal hormone therapy (MHT) on bone mineral density (BMD) in Chinese women. MATERIAL AND METHODS This was a prospective, open-label, randomized-controlled clinical trial. We randomly assigned 123 postmenopausal women to 3 groups: group A received 0.625 mg conjugated equine estrogen (CEE) plus 100 mg micronized progesterone (MP), group B received 0.3 mg CEE daily plus 100 mg MP, and group C received 0.625 mg CEE daily plus 10 mg dydrogesterone (DHG). All subjects received a 2-year intervention and drugs were given in a continuous sequential pattern. RESULTS Ninety-six patients were followed up. At 1 year, groups A and B gained 2.31% and 1.95% BMD, respectively (P<0.01); at 2 years, groups B and C gained 2.37% and 4.15% BMD (P<0.01) respectively. At 2 years, group A gained 3.28% BMD in the femoral neck and 3.77% BMD in Ward's triangle (P<0.05). At 1 year, group B lost 2.14% BMD in the trochanter and 1.20% BMD in the total hip (P<0.05); at 2 years, group B lost 1.51% BMD in the total hip (P<0.01). ALP, Ca, P, and Ca/Cr levels were all decreased in the 3 groups (P<0.05). The changes in Cr level at 1 and 2 years were not significant when compared with baseline in all groups (P>0.05). CONCLUSIONS Both lower-dose and standard-dose CEE increased lumbar BMD, sustain femoral neck BMD, and Ward's triangle BMD, while there was a reduced bone turnover rate. Standard-dose CEE combined with MP can increase BMD at these 2 sites. CEE combined with MP is recommended because it has better clinical benefits.