Cheryl A Sadowski1, Tara Spencer, Nese Yuksel. 1. , BSc(Pharm), PharmD, is with the Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, Alberta.
Abstract
BACKGROUND: The manufacturers of oral bisphosphonates (alendronate, risedronate) recommend avoiding use of these drugs in patients with renal impairment. However, many patients who have osteoporosis or who are at risk of fracture are elderly and may have renal impairment. This situation poses a quandary for clinicians in deciding how best to manage osteoporosis in this high-risk population. OBJECTIVE: To synthesize published evidence regarding the use and safety of oral bisphosphonates for patients with impaired renal function. METHODS: The following databases were searched up to October 2010: PubMed, MEDLINE, Embase, the Cochrane Library, and International Pharmaceutical Abstracts. The following key words and terms were used for the searches: bisphosphonates, alendronate, risedronate, Fosamax, Actonel, "renal failure", "renal insufficiency", "chronic kidney disease", and "end-stage renal disease". The manufacturers of Fosamax and Actonel were asked to provide information about use of their products in patients with renal impairment, including unpublished pharmacokinetic studies or reports of adverse drug events. RESULTS: The search yielded 2 post hoc analyses of safety data, 1 case-control study, 1 case series, 4 retrospective chart analyses, and 2 prospective studies. According to these publications, numerous patients with decreased renal function have received bisphosphonates and have experienced improvement in bone mineral density and/or reduction in risk of fractures, with no increase in adverse effects. Increased renal damage occurred in some individuals with underlying renal disorders, as described in case reports. CONCLUSIONS: Although the literature is limited, there is evidence that alendronate and risedronate are well tolerated and effective when used by individuals with renal impairment. Further research is required to confirm the benefits and risks of using these medications in patients with renal impairment.
BACKGROUND: The manufacturers of oral bisphosphonates (alendronate, risedronate) recommend avoiding use of these drugs in patients with renal impairment. However, many patients who have osteoporosis or who are at risk of fracture are elderly and may have renal impairment. This situation poses a quandary for clinicians in deciding how best to manage osteoporosis in this high-risk population. OBJECTIVE: To synthesize published evidence regarding the use and safety of oral bisphosphonates for patients with impaired renal function. METHODS: The following databases were searched up to October 2010: PubMed, MEDLINE, Embase, the Cochrane Library, and International Pharmaceutical Abstracts. The following key words and terms were used for the searches: bisphosphonates, alendronate, risedronate, Fosamax, Actonel, "renal failure", "renal insufficiency", "chronic kidney disease", and "end-stage renal disease". The manufacturers of Fosamax and Actonel were asked to provide information about use of their products in patients with renal impairment, including unpublished pharmacokinetic studies or reports of adverse drug events. RESULTS: The search yielded 2 post hoc analyses of safety data, 1 case-control study, 1 case series, 4 retrospective chart analyses, and 2 prospective studies. According to these publications, numerous patients with decreased renal function have received bisphosphonates and have experienced improvement in bone mineral density and/or reduction in risk of fractures, with no increase in adverse effects. Increased renal damage occurred in some individuals with underlying renal disorders, as described in case reports. CONCLUSIONS: Although the literature is limited, there is evidence that alendronate and risedronate are well tolerated and effective when used by individuals with renal impairment. Further research is required to confirm the benefits and risks of using these medications in patients with renal impairment.
Authors: Alexandra Papaioannou; Suzanne Morin; Angela M Cheung; Stephanie Atkinson; Jacques P Brown; Sidney Feldman; David A Hanley; Anthony Hodsman; Sophie A Jamal; Stephanie M Kaiser; Brent Kvern; Kerry Siminoski; William D Leslie Journal: CMAJ Date: 2010-10-12 Impact factor: 8.262
Authors: Sophie A Jamal; Douglas C Bauer; Kristine E Ensrud; Jane A Cauley; Marc Hochberg; Areef Ishani; Steven R Cummings Journal: J Bone Miner Res Date: 2007-04 Impact factor: 6.741
Authors: Jane A Cauley; John Robbins; Zhao Chen; Steven R Cummings; Rebecca D Jackson; Andrea Z LaCroix; Meryl LeBoff; Cora E Lewis; Joan McGowan; Joan Neuner; Mary Pettinger; Marcia L Stefanick; Jean Wactawski-Wende; Nelson B Watts Journal: JAMA Date: 2003-10-01 Impact factor: 56.272