Article (Scientific journals)
Bisphosphonates and glucocorticoid osteoporosis in men: results of a randomized controlled trial comparing zoledronic acid with risedronate.
Sambrook, P. N.; Roux, C.; Devogelaer, J. P. et al.
2012In BONE, 50, p. 289-295
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Abstract :
[en] BACKGROUND: We studied 265 men (mean age 56.4years; range 18-83years), 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 7.5mg/day or equivalent) (prevention arm, n=88) or continuing glucocorticoid therapy (treatment arm, n=177). METHODS: Patients received either a single ZOL 5mg infusion or RIS 5mg oral daily at randomization, along with calcium (1000mg) and vitamin D (400-1200IU). Primary endpoint: difference in percentage change from baseline in bone mineral density (BMD) at the lumbar spine (LS) at 12months. 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 1year to a greater extent than daily RIS in men receiving glucocorticoid therapy.
Disciplines :
General & internal medicine
Author, co-author :
Sambrook, P. N.
Roux, C.
Devogelaer, J. P.
Saag, K.
Lau, C. S.
Reginster, Jean-Yves  ;  Université de Liège - ULiège > Département des sciences de la santé publique > Santé publique, Epidémiologie et Economie de la santé
Bucci-Rechtweg, C.
Su, G.
Reid, D. M.
Language :
English
Title :
Bisphosphonates and glucocorticoid osteoporosis in men: results of a randomized controlled trial comparing zoledronic acid with risedronate.
Publication date :
2012
Journal title :
BONE
ISSN :
8756-3282
eISSN :
1873-2763
Publisher :
Elsevier Science, New York, United States - New York
Volume :
50
Pages :
289-295
Peer reviewed :
Peer Reviewed verified by ORBi
Commentary :
Copyright A(c) 2011. Published by Elsevier Inc.
Available on ORBi :
since 22 November 2011

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