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Fracture Preventing Effects of Maxmarvil® Tablets (Alendronate 5 mg + Calcitriol 0.5 µg) in Patients with Osteoporosis

 Jun-Il Yoo  ;  Yong-Chan Ha  ;  Ye-Yeon Won  ;  Kyu-Hyun Yang  ;  Sang-Bum Kim  ;  Ju-Hyung Yoo  ;  Dong-Soo Kim 
 Journal of Bone Metabolism, Vol.24(2) : 91-96, 2017 
Journal Title
Journal of Bone Metabolism
Issue Date
Alendronate ; Bone density ; Calcitriol ; Osteoporosis ; Osteoporotic fractures
BACKGROUND: The purpose of this prospective, open-label, observational study was to assess the fracture preventing effect of Maxmarvil® tablets (alendronate 5 mg + calcitriol 0.5 µg) in patients with osteoporosis and to evaluate the change in bone mineral density (BMD) at the minimum 1-year follow-up.

METHODS: In this multicenter observational study, 691 patients with osteoporosis (aged 50 years or older) were treated with alendronate 5 mg + calcitriol 0.5 µg/day during their normal course of care. Patients were assessed at baseline and at 6 and 12 months. Baseline characteristics (including age, gender, concomitant disease, and baseline fractures) were evaluated.

RESULTS: From among the 848 participants, 149 individuals were lost to follow-up at the time of the study and 8 people had died. The 691 participants (54 men and 637 women) finished the follow-up study and completed the questionnaire. The mean age of the participants was 71.5 years (range, 50-92 years; mean age, 72.3 years for men and 71.4 years for women). Osteoporotic fracture occurred in 19 patients (2.7%). BMD of the lumbar spine and hip was improved by 5% and 1.5% at the latest follow-up. At the latest follow-up, 24 patients (3.5%) complained of drug-related complications such as dyspepsia, constipation, and nausea.

CONCLUSIONS: This prospective observational study demonstrated that alendronate 5 mg + calcitriol 0.5 µg/day had a preventive effect on osteoporotic fracture and it increased the BMD of the lumbar spine by 5% at the latest follow-up.
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1. College of Medicine (의과대학) > Dept. of Orthopedic Surgery (정형외과학교실) > 1. Journal Papers
Yonsei Authors
Yang, Kyu Hyun(양규현) ORCID logo https://orcid.org/0000-0001-7183-588X
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