30th ASBMR 2008
[M363] Effect of Zoledronic Acid (Single 5-mg Infusion) on Lumbar Spine Bone Mineral Density Versus Oral Risedronate (5 mg/day) Over 1 Year in Subgroups of Patients Receiving Glucocorticoid Therapy
C. Roux, D.M. Reid, J.P. Devogelaer, K. Saag, C. Lau, J. Reginster, P. Papanastasiou, A. Ferreira, F. Hartl, T. Fashola, P. Mesenbrink, P. Sambrook.. Paris-Descartes University; University of Aberdeen; Universite Catholique de Louvain; University of Alabama at Birmingham; University of Dundee; University of Leige; Novartis Pharma AG; F. Hoffmann-La Roche Ltd.; Novartis Pharmaceutical Corp.; University of Sydney.
The effects of intravenous zoledronic acid (ZOL, single 5-mg infusion) and oral risedronate (RIS, 5 mg/d) on lumbar spine (LS) bone mineral density (BMD) were evaluated in subgroups of glucocorticoid-treated patients in a 1-year, randomized, double-blind, double-dummy study. Patients were divided into two subpopulations according to glucocorticoid treatment duration at randomization (treatment subpopulation: >3 months [ZOL, n=272; RIS, n=273]; prevention subpopulation: ≤3 months [ZOL, n=144; RIS, n=144]), then further divided into subgroups by gender, age (<35, 35-50, 51-64, 65-74, ≥75 years), mean prednisone dose during the trial (<7.5, ≥7.5 to <12, >12 mg/d), and history of other medications. Increases in LS BMD from baseline to 12 months seen with ZOL were significantly greater than with RIS for: men (P<0.05) and women (P<0.01) for both treatment and prevention subpopulations; age 35-40 years (P=0.0041) and 51-64 years (P=0.0075) for the treatment subpopulation and 65-74 years (P<0.05) for both subpopulations (the difference between ZOL and RIS increased with age); mean prednisone dose ≥7.5 to <12 mg/d (P<0.001) for both subpopulations; no history of proton pump inhibitor (PPI) (P<0.01), selective serotonin reuptake inhibitor (P<0.0001) or anti-tumor necrosis factor (TNF) therapies (P<0.01) for both subpopulations; and prior history of anti-TNF (P=0.0278) and PPI therapies (P=0.0148) for the treatment and prevention subpopulations, respectively. There was no significant difference in increase in LS BMD for ZOL vs RIS for the remaining subgroup parameters in either subpopulation. In the 3 days post treatment, AEs were more common with ZOL (mainly transient post-dose symptoms). From day 3, the 2 treatment groups had similar AE rates. These findings suggest that ZOL is effective in increasing LS BMD to a significantly greater extent than RIS in a wide range of patient subgroups.
C. Roux, Novartis, Amgen, MSD, Alliance, Roche, Servier, Lilly, Nycomed 3, 4.
Novartis
Date: Monday, September 15, 2008
Session Info: Poster: Osteoporosis Treatment (Clinical): Bisphosphonates (11:30 AM-2:30 PM)
Presentation Time: 11:30 AM