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KMID : 1011320090020020105
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Journal of Pharmacoepidemiology and Risk Management
2009 Volume.2 No. 2 p.105 ~ p.113
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Postmarketing Surveillance for the Efficacy and Safety of 12 Months Treatment with Risedronate in Korean Postmenopausal Women with Osteoporosis
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Chang Hye-Mi
Kim Young-Sik
Sun Woo-Sung
Lee Hye-Ree
Cho Be-Long
Cho Chung-Hwan
Suh Young-Sung
Rho Min-Kwan
Choi Youn-Seon
Lee Sang-Yeoup
Kim Cheol-Hwan
Yang Yun-Jun
Moon Yoo-Sun
Korean Post-Marketing Surveillance Research Group
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Abstract
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Objective: Bisphosphonates is most widely used medication for osteoporosis treatment. There are very few studies on the efficacy and safety of bisphosphonates in primary care setting. In order to evaluate the efficacy and safety of the risedronate and related factors about efficacy, an observational study was carried out.
Methods: A total of 517 women with osteoporosis were enrolled by family physicians in 12 hospitals from June 2004 to June 2006. The study subjects took risedronate 35 mg once weekly for 12 months. The questionnaire about baseline characteristics, socioeconomic status and daily calcium intake was performed at the first visit. Adverse events were recoded every 3 months and bone mineral density was measured by Dual X-ray absorptiometry (DEXA) at baseline and 12 months. We evaluated the efficacy of the risedronate and the factors related to the improvement of bone mineral density (BMD) over least significant change after risedronate treatment.
Results: The compliance more than 80% was 88.9% of the patients and continuation rate of the medication was 92.7%. Pre-treatment median BMD was 0.79±0.16 g/cm2 and post-treatment median BMD was 0.84±0.14 g/cm2. Average improvement of BMD was 7.8±19.3%. Of the 317 patients, 155 (48.9%) were improved. The related factors for improvement of BMD were no previous history of osteoporosis treatment (odds ratio 1.79, 95% CI 1.12-2.86) and good compliance (odds ratio 2.55, 95% CI 1.12-5.79).
Conclusion: Risedronate was well tolerated, and BMD was increased in 48.9% of the study subjects after 12 months treatment with risedronate. New users and good compliance were associated with the efficacy of risedronate.
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KEYWORD
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Postmenopausal women, Bone mineral density, Risedronate, Efficacy
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