Fracture Preventing Effects of Maxmarvil® Tablets (Alendronate 5 mg + Calcitriol 0.5 µg) in Patients with Osteoporosis.
10.11005/jbm.2017.24.2.91
- Author:
Jun Il YOO
1
;
Yong Chan HA
;
Ye Yeon WON
;
Kyu Hyun YANG
;
Sang Bum KIM
;
Ju Hyung YOO
;
Dong Soo KIM
Author Information
1. Department of Orthopaedic Surgery, Gyeongsang National University Hospital, Jinju, Korea.
- Publication Type:Multicenter Study ; Original Article
- Keywords:
Alendronate;
Bone density;
Calcitriol;
Osteoporosis;
Osteoporotic fractures
- MeSH:
Alendronate;
Bone Density;
Calcitriol*;
Constipation;
Dyspepsia;
Follow-Up Studies;
Hip;
Humans;
Lost to Follow-Up;
Male;
Nausea;
Observational Study;
Osteoporosis*;
Osteoporotic Fractures;
Prospective Studies;
Spine;
Tablets*
- From:Journal of Bone Metabolism
2017;24(2):91-96
- CountryRepublic of Korea
- Language:English
-
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.
