Patient satisfaction and efficacy of switching from weekly bisphosphonates to monthly minodronate for treatment and prevention of glucocorticoid-induced osteoporosis in Japanese patients with systemic rheumatic diseases: a randomized, clinical trial
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The randomized, clinical trial demonstrated that switching to monthly minodronate from weekly alendronate and risedronate provides greater increases in patients’ satisfaction and bone mineral density and more substantial decreases in a bone resorption marker than continuing weekly alendronate and risedronate in patients with systemic rheumatic diseases on glucocorticoid therapy.
Osteoporosis and associated fractures are major concerns for patients with systemic rheumatic diseases on long-term glucocorticoid therapy. Bisphosphonates increase bone mineral density (BMD) and reduce the frequency of vertebral fractures, but they are associated with poor adherence. The effects of monthly oral minodronate on patients’ satisfaction, BMD, and bone turnover markers were investigated in patients with systemic rheumatic diseases on glucocorticoids and weekly oral alendronate or risedronate.
Study patients with systemic rheumatic diseases on oral glucocorticoids and weekly alendronate 35 mg or risedronate 17.5 mg were randomly assigned either to switch to minodronate 50 mg every 4 weeks or to continue the currently taking weekly bisphosphonate for 52 weeks after a 24-week run-in period.Patients were stratified by hospital site, sex, and menopausal status in women at enrollment. The primary endpoint was the difference between the proportions of patients who responded very satisfactory or satisfactory for the current bisphosphonate therapy at weeks 48 and 76 between the two groups. Secondary endpoints included percentage changes in lumbar spine BMD and bone turnover markers from the time of starting allocated treatment.
Monthly minodronate was superior to weekly alendronate or risedronate for patients’ satisfaction, the increase of lumbar spine BMD, and suppression of serum tartrate-resistant acid phosphatase 5b at week 76.
Monthly minodronate is more acceptable and may be more effective than weekly alendronate or risedronate for prevention and treatment of bone loss in patients with systemic rheumatic diseases on glucocorticoid therapy.
KeywordsGlucocorticoid-induced osteoporosis Glucocorticoid Bisphosphonate Minodronate Alendronate Risedronate
The authors would like to thank Drs. Jun-ichi Wada (Division of Rheumatology, Department of Internal Medicine, Nagoya City University Hospital), who collected the samples of the patients, and Prof. Akio Niimi (Department of Respiratory Medicine, Allergy and Clinical Immunology, Nagoya City University Graduate School of Medical Sciences), who provided general support as a department chair.
Study design: TN. Study conduct and data collection: TN, ST, KS, YH, and SM. Data analysis: TN and ST. Data interpretation: TN and ST. The first draft of the manuscript: ST and TN. Revising manuscript content: TN and ST with assistance in the form of critique and suggestions from all authors. Approving final version of manuscript: all authors. TN takes responsibility for the integrity of the data analysis.
This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
Compliance with ethical standards
Conflict of interest
TN has received research grants from Ono Pharmaceutical Company Limited, Teijin Pharma Limited, and Eisai Company Limited. TN has received lecture fees (< $5000) from Ono Pharmaceutical Company Limited, Teijin Pharma limited, Eisai Company Limited, and Astellas Pharma Incorporated. ST and SM received lecture fees (< $5000) from Ono Pharmaceutical Company Limited. KS received lecture fees (< $5000) from Eisai Company Limited, Astellas Pharm Incorporated, and Takeda Pharmaceutical Company Limited. YH received lecture fees (< $5000) from Takeda Pharmaceutical Company Limited. The other authors declare no conflicts of interest.
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