期刊
BONE
卷 50, 期 1, 页码 289-295出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.bone.2011.10.024
关键词
Glucocorticoids; Osteoporosis; Zoledronic acid; Risedronate; Bone mineral density
资金
- Novartis Pharma AG, Basel, Switzerland
- Merck
- Sanofi -Aventis
- Servier
- Novartis
- Roche
- Australian National Health and Medical Research Council
- Sharpe Dohme
- Alliance
- Amgen
- Nycomed
- Procter Gamble
- Eli Lilly Co
- Aventis
- TAP
- GlaxoSmithKline
- Merckle
- Negma
- Lilly
- Wyeth
- NPS
- Theramex
- UCB
- Shame Dohme
- Rottapharm
- IBSA
- Genevrier
- Teijin
- Teva
- Ebewee Pharma
- Zodiac
- Ana lis
- Novo Nordisk
- Bristol Myers Squibb
Background: We studied 265 men (mean age 56.4 years; range 18-83 years), among patients enrolled in two arms of a double-blind, 1-year study comparing the effects of zoledronic acid (ZOL) with risedronate (RIS) in patients either commencing (prednisolone 7.5 mg/day or equivalent) (prevention arm, n = 88) or continuing glucocorticoid therapy (treatment arm, n = 177). Methods: Patients received either a single ZOL 5 mg infusion or RIS 5 mg oral daily at randomization, along with calcium (1000 mg) and vitamin D (400-1200 ID). Primary endpoint: difference in percentage change from baseline in bone mineral density (BMD) at the lumbar spine (LS) at 12 months. Secondary endpoints: percentage changes in BMD at total hip (TH) and femoral neck (FN), relative changes in bone turnover markers (beta-CTx and P1NP), and overall safety. Findings: In the treatment subpopulation, ZOL increased LS BMD by 4.7% vs. 3.3% for RIS and at TH the percentage changes were 1.8% vs. 0.2%, respectively. In the prevention subpopulation, bone loss was prevented by both treatments. At LS the percentage changes were 2.5% vs. -0.2% for ZOL vs. RIS and at TH the percentage changes were 1.1% vs. -0.4%, respectively. ZOL significantly increased lumbar spine BMD more than RIS at Month 12 in both the prevention population (p = 0.0024) and the treatment subpopulation (p = 0.0232) in men. In the treatment subpopulation, ZOL demonstrated a significantly greater reduction in serum beta-CTx and P1NP relative to RIS at all time-points. In the prevention subpopulation. ZOL significantly reduced beta-CTx at all time-points, and P1NP at Month 3 (p = 0.0297) only. Both treatments were well tolerated in men, albeit with a higher incidence of influenza-like illness and pyrexia events post-infusion with ZOL. Interpretation: Once-yearly ZOL preserves or increases BMD within 1 year to a greater extent than daily RIS ill men receiving glucocorticoid therapy. (C) 2011 Published by Elsevier Inc.
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