Bisphosphonates and glucocorticoid osteoporosis in men: results of a randomized controlled trial comparing zoledronic acid with risedronate

作者：Sambrook Philip N^*; Roux Christian; Devogelaer Jean Pierre; Saag Kenneth; Lau Chak Sing; Reginster Jean Yves; Bucci Rechtweg Christina; Su Guoqin; Reid David M

来源：Bone, 2012, 50(1): 289-295.

DOI：10.1016/j.bone.2011.10.024

• Glucocorticoids
• Osteoporosis
• Zoledronic acid
• Risedronate
• Bone mineral density

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). %26lt;br%26gt;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. %26lt;br%26gt;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. %26lt;br%26gt;Interpretation: Once-yearly ZOL preserves or increases BMD within 1 year to a greater extent than daily RIS ill men receiving glucocorticoid therapy.

• 出版日期2012-1
• 单位河北医科大学