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J Bone Metab. 2017 May;24(2):91-96. doi: 10.11005/jbm.2017.24.2.91. Epub 2017 May 31.

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

Author information

1
Department of Orthopaedic Surgery, Gyeongsang National University Hospital, Jinju, Korea.
2
Department of Orthopaedic Surgery, Chung-Ang University College of Medicine, Seoul, Korea.
3
Department of Orthopaedic Surgery, Ajou University College of Medicine, Suwon, Korea.
4
Department of Orthopaedic Surgery, Yonsei University College of Medicine, Seoul, Korea.
5
Department of Orthopaedic Surgery, Konyang University Hospital, Daejeon, Korea.
6
Department of Orthopaedic Surgery, National Health Insurance Corporation Ilsan Hospital, Goyang, Korea.
7
Department of Orthopaedic Surgery, Chungbuk National University College of Medicine, Cheongju, Korea.

Abstract

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.

KEYWORDS:

Alendronate; Bone density; Calcitriol; Osteoporosis; Osteoporotic fractures

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