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Volume 4 No. 2, April 2009 |
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Efficacy and Tolerability of Raloxifene and Alendronate Therapy, Alone and In Combination, in Postmenopausal Women with Osteoporosis Zakaria Sanad1, Basma Desouky2, Hebba Abbas3, Hesham El-Serougy4, Ayman Khalil5,
Obstetrics and Gynecology1 and Radiodiagnosis2
Departments, Menoufiya University, Al-Abbas Radiology Center3,
Tanta, Clinical Pathology4 and Orthopedics5
Departments, Tanta University, Egypt
Aim: 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. Patients
& Methods: Of the 135 women enrolled, 98 completed this 12 month,
randomized, clinical study (35 in the RLX, 31 in the ALN, and 32 in
the combination groups). 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
lipid profile were measured. Safety was assessed by comparing the
number of women recording any clinical or laboratory adverse
effects. Results: At 12 months, lumbar spine, femoral neck, and
total hip BMD 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
significant increase in the serum high-density lipoprotein
cholesterol in the RLX and combination groups but not in the ALN
group at 12 months. No significant differences in the incidence of
adverse effects especially upper gastrointestinal and vasomotor
symptoms were seen. Conclusion: Treatment of postmenopausal women
with osteoporosis with RLX and ALN, alone and in combination,
significantly increased lumbar spine, femoral neck, and total hip
BMD 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.
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