30th ASBMR 2008
[M362] Effect of a Single 5-mg Infusion of Zoledronic Acid on Bone Turnover Markers Versus Oral Risedronate (5 mg/day) Over 1 Year in Patients With Glucocorticoid-Induced Osteoporosis
P. Sambrook, J.P. Devogelaer, J.Y. Reginster, K. Saag, C. Roux, C.S. Lau, P Papanastasiou, O. Schoenborn-Kellenberger, K. Maylandt, T. Fashola, P. Mesenbrink, D.M. Reid.. University of Sydney; Universite Catholique de Louvain; University of Liege; University of Alabama at Birmingham; Paris-Descartes University; University of Dundee; Novartis Pharma AG; Novartis Pharmaceutical Corp.; University of Aberdeen.
A single zoledronic acid (ZOL, 5 mg) infusion was compared with oral risedronate (RIS, 5 mg/d) in patients with glucocorticoid-induced osteoporosis (GIO) in a 1-yr, double-blind, double-dummy study. Randomized patients were divided into 2 subpopulations: treatment (>3 months glucocorticoid therapy [ZOL, n=272; RIS, n=273]) and prevention (≤3 months glucocorticoids [ZOL, n=144; RIS, n=144]). Bone mineral density (BMD) was evaluated at 6 and 12 months. Changes from baseline in fasting serum β-C-terminal telopeptides of type 1 collagen (β-CTx) and procollagen type 1 amino-terminal propeptide (P1NP) were measured at 9-11 days and Months 3, 6, and 12. ZOL significantly increased lumbar spine (LS) BMD vs RIS in both the treatment (4.1% vs 2.7%; P=0.0001) and prevention (2.6% vs 0.6%; P<0.0001) subpopulations at 12 months. ZOL reduced β-CTx and P1NP levels significantly more than RIS in the treatment (day 9-11 onwards) and prevention (β-CTx, day 9-11 onwards; P1NP, Month 3 onwards) subpopulations (P<0.0001). There was a significant correlation between LS BMD change and some biomarkers at 12 months. In subgroups of patients with/without rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) or asthma/chronic obstructive pulmonary disease (COPD), reductions in β-CTx for ZOL vs RIS were significant from day 9-11 onwards in the combined treatment and prevention subpopulations (P≤0.0004 for all). Reductions in P1NP for ZOL vs RIS were significant from day 9-11 onwards in patients without RA, SLE, and asthma/COPD. In subgroups with/without concomitant use of proton pump inhibitors (PPIs), selective serotonin inhibitors (SSRIs) or anti-tumor necrosis factor (anti-TNF) at baseline there was no difference in reductions in β-CTx levels for ZOL vs RIS (P<0.001). P1NP levels were significantly reduced for ZOL vs RIS from day 9-11 onwards, regardless of PPI use (P≤0.0002) or anti-TNF use (P≤0.0001), but was only significantly reduced at all timepoints in patients not taking SSRIs (P<0.001). These results indicate that a single infusion of ZOL suppresses bone turnover significantly more than daily oral RIS for up to 1 yr in different subgroups of patients with GIO.
P. Sambrook, Merck 1, 4; Sanofi-Aventis 1, 4; Novartis 1, 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