Osteoporos Sarcopenia.  2020 Dec;6(4):191-198. 10.1016/j.afos.2020.11.002.

A 3-year postmarketing study on the safety and effectiveness of once-monthly risedronate in Japanese patients with osteoporosis

Affiliations
  • 1Soen Orthopaedics, Osteoporosis and Rheumatology Clinic, Kobe, Japan
  • 2Post-Marketing Medical Research Group, Medical Department, EA Pharma Co., Ltd., Tokyo, Japan
  • 3Clinical Development Department, Data Science Group, EA Pharma Co., Ltd., Tokyo, Japan
  • 4Clinical Planning Department, Medical HQs, Eisai Co., Ltd., Tokyo, Japan

Abstract


Objectives
This postmarketing study aims to evaluate the safety and effectiveness of oral administration of risedronate at 75 mg once monthly for 36 months in patients with osteoporosis in Japan.
Methods
Participants were ambulatory outpatients with osteoporosis who were ≥ 50 years old and had prevalent vertebral fractures. Outcomes were the incidence rate of adverse drug reaction (ADR), cumulative incidence of vertebral, nonvertebral, and hip fractures, the percent changes of lumbar spinal L2–4 bone mineral density (BMD), and low back pain. In addition, medication compliance was examined.
Results
Safety, vertebral fractures, and other outcomes were analyzed in 542, 328, and 535 patients, respectively. In the safety analysis set, 88.38% of the patients were women and the mean age was 75.9 years. The monthly medication compliance rate ranged from 83.24% to 95.38%. The incidence rate of ADRs, including 4 severe ADRs, was 10.52% (n = 57). The common ADRs were gastrointestinal disorders, musculoskeletal, and connective tissue disorders. No osteonecrosis of the jaw was reported. The cumulative incidences (95% CI) of vertebral, nonvertebral, and hip fractures at 36 months were 12.58% (8.61–18.18), 6.59% (4.31–10.01), and 1.58% (0.64–3.88), respectively. The L2–4 BMD increased by 10.59% compared with baseline value (P < 0.01), and the proportion of patients with low back pain decreased to 30.77%, at 36 months.
Conclusions
Administering 75 mg of risedronate once a month remains a favorable compliance rate and may be useful for the treatment of patients, even the elderly, with osteoporosis in daily practice.

Keyword

Once-monthly risedronate; Postmarketing survey; Osteoporosis; Medication compliance; Vertebral fracture; Low back pain
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