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Risedronate therapy in patients with mild-to-moderate chronic kidney disease with osteoporosis: post-hoc analysis of
Takashi Shigematsu1, Ryoichi Muraoka2, Toshitsugu Sugimoto3
1Department of Nephrology, Wakayama Medical University, 811-1 Kimiidera, Wakayama-City, Wakayama, 641-8509, Japan. taki@wakayama-med.ac.jp.
Insights
Risedronate therapy is effective for Japanese osteoporosis patients with chronic kidney disease (CKD). Treatment showed similar bone mineral density increases and bone turnover marker inhibition across different kidney function levels, with no adverse kidney effects.
Area of Science:
- Nephrology
- Endocrinology
- Rheumatology
Background:
- Limited data on bisphosphonate efficacy in Japanese Chronic Kidney Disease (CKD) patients with osteoporosis.
- This study analyzes Japanese phase III risedronate trials to evaluate treatment effects in CKD patients.
Purpose of the Study:
- To evaluate the clinical effect of risedronate therapy in Japanese osteoporosis patients with varying degrees of kidney function.
- To assess the safety and efficacy of risedronate in relation to estimated glomerular filtration rate (eGFR) levels.
Main Methods:
- Analysis of 852 Japanese subjects from three risedronate phase III trials.
- Subjects received risedronate (2.5 mg daily or 17.5 mg weekly) with eGFR ≥ 30 mL/min.
- Patients were categorized into eGFR subgroups (≥90, 60-89, 30-59 mL/min/1.73 m²); lumbar spine BMD, BTMs, and adverse events were assessed at 48 weeks.
Main Results:
- Risedronate administration demonstrated a significant increase in lumbar spine bone mineral density (BMD) across all eGFR subgroups.
- Bone turnover markers (BTMs) were significantly inhibited, indicating therapeutic effect.
- Adverse event incidence was comparable among subgroups, and no kidney function deterioration was observed in patients with eGFR > 30 mL/min/1.73 m².
Conclusions:
- Risedronate therapy is clinically effective for Japanese osteoporosis patients with CKD.
- The therapeutic effects of risedronate were consistent across different levels of kidney function.
- Risedronate is a safe and effective treatment option for osteoporosis in CKD patients with eGFR ≥ 30 mL/min/1.73 m².
Background:
The clinical effect of bisphosphonate treatment has not been clearly evaluated by kidney function in Japanese Chronic Kidney Disease (CKD) patients with osteoporosis. This study analyzed the data from three risedronate Japanese phase III trials. The clinical effect of risedronate therapy was evaluated in CKD patients with osteoporosis.
Methods:
The Japanese clinical trials involved 852 subjects who received risedronate (2.5 mg once daily or 17.5 mg once weekly) and whose estimated glomerular filtration rate (eGFR) were calculable and at ≥ 30 mL/min. The subjects were divided into subgroups according to the eGFR level: ≥ 90 mL/min/1.73 m2, ≥ 60 to < 90 mL/min/1.73 m2, ≥ 30 to < 60 mL/min/1.73 m2. Lumbar spine bone mineral density (BMD), bone turnover markers (BTMs) and adverse events were evaluated at 48 weeks.
Results:
Adverse event incidence was similar among three subgroups. There was also no exacerbation of impaired kidney function associated with risedronate administration in the subjects with eGFR above 30 mL/min/1.73 m2. Risedronate administration induced a significant increase in lumbar spine BMD and significant inhibition of BTMs in three subgroups.
Conclusions:
The risedronate therapy showed similar clinical effects in CKD patients with osteoporosis compared to those without CKD.
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