OBJECTIVE: To compare the effects of two doses of piperazine oestrone sulphate combined with interrupted norethisterone, with that of oestradiol continuously combined with norethisterone acetate, and with placebo, in postmenopausal women. DESIGN: A prospective randomised trial. PARTICIPANTS: Two hundred postmenopausal women. SETTING:Monocentre study with expertise in osteoporosis. METHODS: The participants were randomly assigned to two years of treatment with alternating three-day cycles of 1.5 mg of piperazine oestrone sulphate plus 0.7 mg of norethisterone (highEP), or alternating three-day cycles of 0.75 mg of piperaine oestrone sulphate plus 0.35 mg of norethisterone (lowEP), or 2 mg of 17beta-oestradiol continuously combined with 1 mg of norethisterone acetate (E2+NETA), or placebo. MAIN OUTCOME MEASURES: Change in bone mineral density, lipoprotein metabolism, climacteric symptoms, and adverse effects. RESULTS:One hundred and twenty-one women completed the study. Spinal bone mineral density was increased about 9% over two years by E2+NETA, about 6% by highEP, 4% by lowEP, but remained unchanged in the placebo group. The same pattern was seen in the hip and forearm. All hormone regimens decreased markers of bone turnover and alleviated climacteric symptoms. Serum lipoproteins decreased by about 10% in all hormone groups. CONCLUSIONS: All hormone regimens studied prevented bone loss completely and lowered serum lipids.
RCT Entities:
OBJECTIVE: To compare the effects of two doses of piperazine oestrone sulphate combined with interrupted norethisterone, with that of oestradiol continuously combined with norethisterone acetate, and with placebo, in postmenopausal women. DESIGN: A prospective randomised trial. PARTICIPANTS: Two hundred postmenopausal women. SETTING: Monocentre study with expertise in osteoporosis. METHODS: The participants were randomly assigned to two years of treatment with alternating three-day cycles of 1.5 mg of piperazine oestrone sulphate plus 0.7 mg of norethisterone (highEP), or alternating three-day cycles of 0.75 mg of piperaine oestrone sulphate plus 0.35 mg of norethisterone (lowEP), or 2 mg of 17beta-oestradiol continuously combined with 1 mg of norethisterone acetate (E2+NETA), or placebo. MAIN OUTCOME MEASURES: Change in bone mineral density, lipoprotein metabolism, climacteric symptoms, and adverse effects. RESULTS: One hundred and twenty-one women completed the study. Spinal bone mineral density was increased about 9% over two years by E2+NETA, about 6% by highEP, 4% by lowEP, but remained unchanged in the placebo group. The same pattern was seen in the hip and forearm. All hormone regimens decreased markers of bone turnover and alleviated climacteric symptoms. Serum lipoproteins decreased by about 10% in all hormone groups. CONCLUSIONS: All hormone regimens studied prevented bone loss completely and lowered serum lipids.