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  • Effect of raloxifene hydrochloride on bone mineral density and bone turnover in Kuwaiti postmenopausal women with osteoporosis.

Effect of raloxifene hydrochloride on bone mineral density and bone turnover in Kuwaiti postmenopausal women with osteoporosis.

Archives of osteoporosis (2014-07-20)
Ibrahim A Abdelazim, Khaled M Abdelrazak, Mohamed Al-Kadi, Amr H Yehia, Bassam M Sami Nusair, Mohannad Abu Faza
ABSTRACT

Osteoporosis is a major cause of mortality and morbidity worldwide. Decreased bone turnover markers and increased lumbar spine and total hip bone mineral density (BMD) in raloxifene-treated women add further support to the idea that raloxifene is an effective well-tolerated option for treating Kuwaiti postmenopausal osteoporosis, suitable for long-term use. Osteoporosis is currently a major cause of mortality, morbidity, and medical expense worldwide, and it is important to investigate therapies for the prevention and treatment of osteoporosis in postmenopausal women. This study was designed to detect the effect of raloxifene hydrochloride on bone mineral density and bone turnover in Kuwaiti postmenopausal women with osteoporosis. Postmenopausal women who were free of severe or chronically disabling conditions, had their last menstrual period at least 2 years before the beginning of the study, had a T score for femoral neck or lumbar spine BMD measurements ≤2.5, and were without fractures were included in this study. One hundred and seventy-six (176) women were included in this study and were divided into two groups; the first group (study) received raloxifene with calcium and vitamin D daily for 12 months, and the second group (control) received only calcium and vitamin D. BMD and bone metabolism markers were measured before and after treatment. One year after treatment, BMD of lumbar spine and total hip was significantly increased in study group (3.21 ± 5.4 and 1.62 ± 7.4, respectively) compared to controls (0.9 ± 3.8 and -0.8 ± 5.6, respectively); also, Ward's triangle and trochanter BMD was significantly increased in study group (4.84 ± 9.3 and 1.78 ± 8.5, respectively) compared to controls (1.53 ± 6.6 and -1. 4 ± 6.4, respectively). C-telopeptide was significantly decreased in study group (121 ± 7.8) compared to control group (1,480 ± 6.3); also, serum osteocalcin was significantly decreased in study group (14.5 ± 8.3) compared to control group (43.8 ± 1.3) 1 year after treatment. Occurrence of fractures during this study was significantly low in raloxifene group compared to controls (0 (0%) versus 3 (3.6%), respectively). Raloxifene appears to be an effective, well-tolerated option for treating osteoporosis in Kuwaiti postmenopausal women, suitable for long-term use.

MATERIALS
Product Number
Brand
Product Description

USP
Raloxifene hydrochloride, United States Pharmacopeia (USP) Reference Standard
Sigma-Aldrich
Raloxifene hydrochloride, solid
Raloxifene hydrochloride, European Pharmacopoeia (EP) Reference Standard
Raloxifene hydrochloride for peak identification, European Pharmacopoeia (EP) Reference Standard