Osteoporos Sarcopenia.  2018 Mar;4(1):22-28. 10.1016/j.afos.2018.01.001.

Safety and effectiveness of monthly intravenous ibandronate injections in a prospective, postmarketing, and observational study in Japanese patients with osteoporosis

Affiliations
  • 1Endocrine Center, Toranomon Hospital, Okinaka Memorial Institute for Medical Research, Tokyo, Japan.
  • 2Project & Lifecycle Management Unit, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan. hashimotojnk@chugai-pharm.co.jp
  • 3Drug Safety Division, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.

Abstract


OBJECTIVES
This postmarketing, observational study evaluated the safety and effectiveness of monthly intravenous (IV) ibandronate in Japanese patients with osteoporosis.
METHODS
Eligible patients received monthly IV ibandronate 1mg for 12 months. Adverse drug reactions (ADRs) were evaluated. Changes in bone mineral density (BMD) and bone turnover markers (BTMs) were assessed using matched t-test analysis. Cumulative fracture rates were analyzed by Kaplan-Meier methodology.
RESULTS
In total, 1062 patients were enrolled, of whom 1025 (n = 887 women, n = 138 men) were treated. Mean patient age was 77 years. Seventy-five ADRs were reported in 54 patients (5.26%). Four patients (0.39%) experienced serious ADRs, including one case of osteonecrosis of the jaw. Acute-phase reactions occurred in 21 patients (2.04%), and half of them arose after the first ibandronate injection. No new safety concerns were identified. Significant increases in BMD at 12 months relative to baseline were observed at the lumbar spine (4.84%, n = 187; 95% confidence interval [CI], 3.47%-6.21%), femoral neck (2.73%, n = 166; 95% CI, 1.46%-4.01%), and total hip (1.93%, n = 133; 95% CI, 0.80%-3.07%). Significant reductions were observed in all BTMs at 12 months (n = 174 in tartrate-resistant acid phosphatase-5b, n = 101 in procollagen type 1 N-terminal propeptide at baseline). The cumulative incidence of nontraumatic, new vertebral and nonvertebral fractures was 3.16% (95% CI, 2.12%-4.70%). Analyses in women only showed similar results to the overall population.
CONCLUSIONS
These findings confirm the favorable safety and consistent effectiveness of ibandronate, and indicate that monthly IV ibandronate would be beneficial in daily practice for the treatment of Japanese patients with osteoporosis.

Keyword

Ibandronate; Intravenous; Japan; Osteoporosis; Prospective observational study

MeSH Terms

Asian Continental Ancestry Group*
Bone Density
Bone Remodeling
Drug-Related Side Effects and Adverse Reactions
Female
Femur Neck
Hip
Humans
Incidence
Japan
Jaw
Observational Study*
Osteonecrosis
Osteoporosis*
Procollagen
Prospective Studies*
Spine
Procollagen
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