Long-term Safety and Effectiveness of Denosumab in Japanese Patients with Osteoporosis: 3-Year Post-marketing Surveillance Study

Q: What was the purpose of the denosumab post-marketing surveillance study?

To investigate the long-term safety and effectiveness of denosumab in Japanese patients with osteoporosis in daily clinical practice.

Q: How was the study designed and what time points were assessed?

It was a 3-year, prospective, observational cohort study. Data were assessed at baseline and at 3, 6, 12, 24, and 36 months.

Q: What were the key safety and effectiveness findings over 3 years?

ADRs occurred in 8.4% of 3534 patients, with hypocalcaemia as the most common (3.9%). Lumbar spine BMD increased (mean +11.4% at 36 months), bone turnover markers decreased, and 3.3% developed new osteoporotic fractures.

Jul 10, 2026

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Denosumab, a humanized IgG2 monoclonal antibody approved in Japan for osteoporosis since 2013, is evaluated for long-term real-world performance. A prospective, observational 3-year post-marketing surveillance study assessed patients starting denosumab 60 mg every 6 months at baseline and 3, 6, 12, 24, and 36 months, focusing on adverse events, ADRs, osteoporotic fractures, bone mineral density, and bone turnover markers. Among 3534 patients (mean age 75.7), ADRs occurred in 8.4%, mainly hypocalcaemia, while lumbar spine BMD increased and bone turnover markers declined, with 3.3% sustaining new fractures; no new safety signals emerged.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages11

Reading Time28 min

Abstract

Introduction

Materials and methods

Results

Conclusions

Introduction

Materials and methods

Study design

Journal of Bone and Mineral Metabolism (2021) 39:463–473 [https://doi.org/10.1007/s00774-020-01](https://doi.org/10.1007/s00774-020-01)180-4 Long‑term safety and effectiveness of denosumab in Japanese patients with osteoporosis: 3‑year post‑marketing surveillance study Sakae Tanaka1 · Hideki Mizutani2 · Eri Tsuruya2 · Ryoko Fukuda2 · Kiyoka Kuge2 · Naoki Okubo3 Received: 4 March 2020 / Accepted: 4 November 2020 / Published online: 2 January 2021 © The Japanese Society Bone and Mineral Research 2021 Abstract Introduction Denosumab is a humanized IgG2 monoclonal antibody that was approved for the treatment of osteoporosis in Japan in 2013. This study aimed to investigate the long-term safety and effectiveness of denosumab in Japanese patients with osteoporosis in daily clinical practice. Materials and methods This 3-year, prospective, observational, post-marketing study included patients who initiated treatment with denosumab (60 mg/6 months) for osteoporosis. Data were assessed at baseline, 3, 6, 12, 24 and 36 months. Key endpoints were adverse events (AEs), adverse drug reactions (ADRs), occurrence of osteoporotic fractures, bone mineral density (BMD), and bone turnover markers. Multivariate analyses were conducted to identify predictors of hypocalcaemia and percent change in BMD. Results Overall, 3534 patients were assessed (mean 75.7 years; 89.8% women). In total, 298 patients (8.4%) developed ADRs; the most common was hypocalcaemia (3.9%) . Hypocalcaemia risk was significantly increased in patients with creatinine clearance < 30 mL/min, no prior use ofbisphosphonates, prior use of calcium and vitamin D preparations, baseline serum calcium < 8.5 mg/dL, and no concomitant use of calcium or vitamin D preparations. Six patients had adjudicated osteonecrosis of the jaw. Lumbar spine BMD increased significantly from baseline (mean percent change: 11.4% at 36 months) . All bone turnover markers decreased significantly from baseline. Over 3 years, 3.3% of patients developed a new osteoporotic fracture. Conclusions This study confirmed the long-term safety and effectiveness of denosumab in Japanese patients with osteoporosis in daily clinical practice. No new safety signals were identified. Keywords Denosumab · Hypocalcaemia · Japanese · Osteoporosis · Real-world survey Introduction Osteoporosis is a disease characterized by low bone mineral density (BMD) and abnormal bone microstructure, which results in bone fragility and increased risk of fracture [1–3] . Electronic supplementary material The online version of this article ([https://doi.org/10.1007/s00774-020-01180-4](https://doi.org/10.1007/s00774-020-01180-4)) contains supplementary material, which is available to authorized users. * Hideki Mizutani [mizutani.hideki.m5@daiichisankyo.co.jp](mizutani.hideki.m5@daiichisankyo.co.jp) 1 Department of Orthopaedic Surgery, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan 2 Post Marketing Study Department, Daiichi Sankyo Co., Ltd., 3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo 103-8426, Japan 3 Biostatistics and Data Management Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan The changes to bone microarchitecture in osteoporosis are insidious and asymptomatic, so many patients are not diagnosed until they develop a fracture [3]. Once patients experience a fracture, it can have a major effect on their daily life, quality of life (QoL), ability to live independently, and their prognosis [4, 5] . An estimated 12–15 million people in Japan have osteoporosis, and ~ 150,000 people develop a new osteoporotic fracture each year [2, 6, 7] . Therefore, Japanese guidelines for the management of osteoporosis define fracture prevention as the key goal of osteoporosis treatment. Denosumab (Pralia®) is a humanized IgG2 monoclonal antibody that was approved for treatment of osteoporosis in Japan in 2013. Denosumab acts by blocking the action of receptor activator o

FAQs

What was the purpose of the denosumab post-marketing surveillance study?

To investigate the long-term safety and effectiveness of denosumab in Japanese patients with osteoporosis in daily clinical practice.

How was the study designed and what time points were assessed?

It was a 3-year, prospective, observational cohort study. Data were assessed at baseline and at 3, 6, 12, 24, and 36 months.

What were the key safety and effectiveness findings over 3 years?

ADRs occurred in 8.4% of 3534 patients, with hypocalcaemia as the most common (3.9%). Lumbar spine BMD increased (mean +11.4% at 36 months), bone turnover markers decreased, and 3.3% developed new osteoporotic fractures.

Jul 10, 2026

Upload by Jiven