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Safety and efficacy of risedronate in patients with age-related reduced renal function as estimated by the Cockcroft and Gault method: a pooled analysis of nine clinical trials.
J Bone Miner Res. 2005 Dec; 20(12):2105-15.JB

Abstract

The incidences of osteoporosis and renal insufficiency increase with age. We studied the influence of renal function on the safety and efficacy of risedronate 5 mg daily in osteoporotic women. Risedronate was safe and effective in osteoporotic women with mild, moderate, or severe age-related renal impairment.

INTRODUCTION

The incidences of both osteoporosis and renal insufficiency increase with age; thus, the effect of renal impairment on the safety and efficacy of osteoporosis treatments is a clinical concern. Risedronate is a pyridinyl bisphosphonate well established as safe and effective in the treatment and prevention of osteoporosis. Currently, there is little available information about the effect of bisphosphonate treatment in patients with renal insufficiency. This retrospective analysis was conducted to study the influence of renal function on the safety and efficacy of risedronate in a population of osteoporotic women.

MATERIALS AND METHODS

Combined data from nine randomized, double-blind, placebo-controlled phase III risedronate trials were analyzed. The patients in these studies had no markedly abnormal laboratory parameters that were considered clinically significant and no evidence of significant disease. This analysis included patients who received placebo (n = 4,500) or risedronate 5 mg (n = 4,496) for up to 3 years (average duration of exposure, 2 years) and who had renal impairment (creatinine clearance [CrCl] < 80 ml/min). CrCl was estimated by the Cockcroft and Gault method, based on age, weight, and serum creatinine. Patients were categorized as having mild (CrCl >or=50 to <80 ml/min), moderate (CrCl >or=30 to <50 ml/min), or severe (CrCl < 30 ml/min) renal impairment.

RESULTS

Of the patients studied, renal impairment at baseline was mild in 48% (mean [range] serum creatinine, 0.9 [0.4-1.6] mg/dl), moderate in 45% (1.1 [0.6-1.9] mg/dl), and severe in 7% (1.3 [0.7-2.7] mg/dl). In both the placebo and risedronate treatment groups, the patients with the most severe renal impairment were older and had more severe osteoporosis. The incidences of overall adverse events and of renal function-related adverse events were similar in the placebo and risedronate 5 mg groups regardless of renal function. Furthermore, evaluation of changes from baseline in serum creatinine revealed no difference in renal function between the placebo and risedronate 5 mg groups in any of the renal impairment subgroups at any time-point. In all three subgroups, risedronate effectively preserved BMD and reduced the incidence of vertebral fractures.

CONCLUSIONS

These findings show that risedronate is safe and effective in osteoporotic women with age-related mild, moderate, or severe renal impairment.

Authors+Show Affiliations

University of Colorado Health Science Center, Colorado Center for Bone Research, Lakewood, USA. MillerCCBR@aol.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16294264

Citation

Miller, Paul D., et al. "Safety and Efficacy of Risedronate in Patients With Age-related Reduced Renal Function as Estimated By the Cockcroft and Gault Method: a Pooled Analysis of Nine Clinical Trials." Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research, vol. 20, no. 12, 2005, pp. 2105-15.
Miller PD, Roux C, Boonen S, et al. Safety and efficacy of risedronate in patients with age-related reduced renal function as estimated by the Cockcroft and Gault method: a pooled analysis of nine clinical trials. J Bone Miner Res. 2005;20(12):2105-15.
Miller, P. D., Roux, C., Boonen, S., Barton, I. P., Dunlap, L. E., & Burgio, D. E. (2005). Safety and efficacy of risedronate in patients with age-related reduced renal function as estimated by the Cockcroft and Gault method: a pooled analysis of nine clinical trials. Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research, 20(12), 2105-15.
Miller PD, et al. Safety and Efficacy of Risedronate in Patients With Age-related Reduced Renal Function as Estimated By the Cockcroft and Gault Method: a Pooled Analysis of Nine Clinical Trials. J Bone Miner Res. 2005;20(12):2105-15. PubMed PMID: 16294264.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of risedronate in patients with age-related reduced renal function as estimated by the Cockcroft and Gault method: a pooled analysis of nine clinical trials. AU - Miller,Paul D, AU - Roux,Christian, AU - Boonen,Steven, AU - Barton,Ian P, AU - Dunlap,Lisa E, AU - Burgio,David E, Y1 - 2005/08/22/ PY - 2005/03/09/received PY - 2005/07/18/revised PY - 2005/08/15/accepted PY - 2005/11/19/pubmed PY - 2006/2/28/medline PY - 2005/11/19/entrez SP - 2105 EP - 15 JF - Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research JO - J Bone Miner Res VL - 20 IS - 12 N2 - UNLABELLED: The incidences of osteoporosis and renal insufficiency increase with age. We studied the influence of renal function on the safety and efficacy of risedronate 5 mg daily in osteoporotic women. Risedronate was safe and effective in osteoporotic women with mild, moderate, or severe age-related renal impairment. INTRODUCTION: The incidences of both osteoporosis and renal insufficiency increase with age; thus, the effect of renal impairment on the safety and efficacy of osteoporosis treatments is a clinical concern. Risedronate is a pyridinyl bisphosphonate well established as safe and effective in the treatment and prevention of osteoporosis. Currently, there is little available information about the effect of bisphosphonate treatment in patients with renal insufficiency. This retrospective analysis was conducted to study the influence of renal function on the safety and efficacy of risedronate in a population of osteoporotic women. MATERIALS AND METHODS: Combined data from nine randomized, double-blind, placebo-controlled phase III risedronate trials were analyzed. The patients in these studies had no markedly abnormal laboratory parameters that were considered clinically significant and no evidence of significant disease. This analysis included patients who received placebo (n = 4,500) or risedronate 5 mg (n = 4,496) for up to 3 years (average duration of exposure, 2 years) and who had renal impairment (creatinine clearance [CrCl] < 80 ml/min). CrCl was estimated by the Cockcroft and Gault method, based on age, weight, and serum creatinine. Patients were categorized as having mild (CrCl >or=50 to <80 ml/min), moderate (CrCl >or=30 to <50 ml/min), or severe (CrCl < 30 ml/min) renal impairment. RESULTS: Of the patients studied, renal impairment at baseline was mild in 48% (mean [range] serum creatinine, 0.9 [0.4-1.6] mg/dl), moderate in 45% (1.1 [0.6-1.9] mg/dl), and severe in 7% (1.3 [0.7-2.7] mg/dl). In both the placebo and risedronate treatment groups, the patients with the most severe renal impairment were older and had more severe osteoporosis. The incidences of overall adverse events and of renal function-related adverse events were similar in the placebo and risedronate 5 mg groups regardless of renal function. Furthermore, evaluation of changes from baseline in serum creatinine revealed no difference in renal function between the placebo and risedronate 5 mg groups in any of the renal impairment subgroups at any time-point. In all three subgroups, risedronate effectively preserved BMD and reduced the incidence of vertebral fractures. CONCLUSIONS: These findings show that risedronate is safe and effective in osteoporotic women with age-related mild, moderate, or severe renal impairment. SN - 0884-0431 UR - https://www.unboundmedicine.com/medline/citation/16294264/Safety_and_efficacy_of_risedronate_in_patients_with_age_related_reduced_renal_function_as_estimated_by_the_Cockcroft_and_Gault_method:_a_pooled_analysis_of_nine_clinical_trials_ L2 - https://doi.org/10.1359/JBMR.050817 DB - PRIME DP - Unbound Medicine ER -