Background Raloxifene (RLX) is a selective oestrogen receptor modulator (SERM) and exerts a positive estrogenic activity on bone and on serum lipids. The purpose of this randomised study was to access the effect of RLX on Bone Mineral Density (BMD) and on serum lipids in postmenopausal (PM) women with severe osteopenia and/or osteoporosis according to WHO criteria.
Objectives 100 PM women were randomly assigned to either RLX 60 mg/day+600 mg Calcium Carbonate (CC) (70 women) or 600 mg of CC alone (30 women), as controls, for 12 months. The two groups of women had similar anthropometric data, mean age (56,98 ± 5,1 yrs) and mean postmenopausal age (9,4 ± 5,2 yrs).
Methods BMD was measured at baseline and at 12 months of therapy, using DEXA (Hologic 1000 QDR) at Lumbar Spine (LS) and Lft Femur (FN)(neck). Serum total Cholesterol, LDL, HDL, triglycerides were measured at baseline, 6 and 12 months (photometric method). Results are expressed as percentage change from baseline. Statistics were done using t-test (unpaired).
Results Bone loss prevented only in the group of RLX. The BMD increased at LS = +2,3(± 2,8)% and at FN = 1,4 (± 2,6)%. In the group of controls the BMD diminished at LS -1,2(± 1,1)% and at FN -1,5(± 2,4)%. The difference in BMD changes between the two groups was significant (p < 0,05). There was no change in HDL, LDL and triglycerides in either group. Only Total Cholesterol decreased significantly (p < 0,05) in RLX group. No clinically relevant effects on safety parameters (liver enzymes, hematologic variables and vital signs) were recorded.
Conclusion We conclude that RLX proved to be effective and safe in the prophylaxis and treatment of postmenopausal severe osteopenia and/or osteoporosis.
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