title: The effect of raloxifene treatment in postmenopausal women with CKD.
abstract: It is unknown whether treatment for osteoporosis with raloxifene is safe or effective in those with chronic kidney disease (CKD). With data from a multicenter, randomized, placebo-controlled trial of 7705 postmenopausal women with osteoporosis, the effect of raloxifene on rate of change of bone mineral density (BMD), incidence of fractures, and adverse events by stage of CKD was examined over 3 yr. Baseline serum creatinine values were available for 7316 women, and these values were used to assign a category of creatinine clearance (CrCl) using the Cockcroft-Gault formula (CrCl < 45, 45 to 59, and > or = 60 ml/min). BMD was measured at baseline and annually by dual x-ray absorptiometry. Within the placebo group, lower baseline CrCl was associated with a trend for higher annual losses of BMD at the femoral neck; however, within the raloxifene group, lower baseline CrCl was associated with greater increases in femoral neck BMD. This interaction between category of CrCl and treatment assignment was significant for rate of change of BMD at the hip. Irrespective of kidney function, raloxifene treatment was associated with a greater increase in spine BMD, a reduction in vertebral fractures, and no effect on nonvertebral fractures compared with placebo. Within each category of kidney function, adverse events were similar between the raloxifene and placebo groups. In conclusion, raloxifene increases BMD at both the hip and the spine and reduces the risk for vertebral fractures among individuals with CKD. The effect ofraloxifene on hip BMD is greater among those with mild to moderate CKD.
authors.affiliation: Center for Chronic Disease Outcomes Research, Veterans Affairs Medical Center, and Department of Medicine and Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN 55417, USA. isha0012@umn.edu
authors.forename: Areef
authors.initials: A
authors.lastname: Ishani
authors.forename: Terri
authors.initials: T
authors.lastname: Blackwell
authors.forename: Sophie A
authors.initials: SA
authors.lastname: Jamal
authors.forename: Steven R
authors.initials: SR
authors.lastname: Cummings
authors.forename: Kristine E
authors.initials: KE
authors.lastname: Ensrud
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007676:Kidney Failure, Chronic / Q000150:complications*; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000150:complications / Q000188:drug therapy*; D020849:Raloxifene Hydrochloride / Q000009:adverse effects / Q000627:therapeutic use*; D016103:Spinal Fractures / Q000209:etiology / Q000517:prevention & control
chemical_list: D050071:Bone Density Conservation Agents; D020849:Raloxifene Hydrochloride