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Abstract
Objectives To compare the efficacy and tolerability of raloxifene (RLX) 60 mg daily and alendronate (ALN) 70 mg once weekly, either alone or in combination, on bone mineral density (BMD), bone turnover, and lipid metabolism in postmenopausal women with osteoporosis.
Methods Of the 135 women enrolled, 98 completed this 12-month, randomized, clinical study (35 in the RLX group, 31 in the ALN group, and 32 in the combination group). Measurements were taken of the BMD of the lumbar spine, femoral neck and total hip, urinary N-telopeptide (NTx) of type I collagen corrected for creatinine, serum bone-specific alkaline phosphatase (BSAP), and the lipid profile. All adverse effects were recorded.
Results At 12 months, the BMD of the lumbar spine, femoral neck, and total hip significantly increased from baseline in all treatment groups. However, the increase in BMD in the combination group was significantly greater than those in the RLX and ALN groups (p < 0.0001). The reductions in both urinary NTx and serum BSAP in the combination and ALN groups were significantly greater than those in the RLX group (p < 0.0001). There were significant reductions in the serum total cholesterol and low density lipoprotein cholesterol and a significant increase in the serum high density lipoprotein cholesterol in the RLX and combination groups but not in the ALN group at 12 months. There were no significant differences in the incidence of adverse effects.
Conclusions Treatment of postmenopausal women with osteoporosis with RLX and ALN, alone and in combination, significantly increased the BMD of the lumbar spine, femoral neck and total hip and reduced markers of bone turnover. However, the effects of combined therapy were more pronounced than those of either monotherapy. On the other hand, RLX had some beneficial effects on lipid metabolism. Both medications, alone or in combination, had similar tolerability and safety profiles.