TY - JOUR
T1 - Effect on bone turnover markers of once-yearly intravenous infusion of zoledronic acid versus daily oral risedronate in patients treated with glucocorticoids
AU - Devogelaer, Jean Pierre
AU - Sambrook, Philip
AU - Reid, David M.
AU - Goemaere, Stefan
AU - Ish-Shalom, Sophia
AU - Collette, Julien
AU - Su, Guoqin
AU - Bucci-Rechtweg, Christina
AU - Papanastasiou, Philemon
AU - Reginster, Jean Yves
N1 - Funding: The study was financially supported by Novartis Pharma AG.
PY - 2013/6/1
Y1 - 2013/6/1
N2 - Objective: Long-term glucocorticoid use is accompanied by rapid bone loss; however, early treatment with bisphosphonates prevents bone loss and reduces fracture risk. The aim of this study was to examine the effects of two bisphosphonates, i.v. zoledronic acid (ZOL) versus oral risedronate (RIS), on bone turnover markers (BTMs) in subjects with glucocorticoid-induced osteoporosis (GIO). Methods: Patients were randomly stratified according to the duration of pre-study glucocorticoid therapy [prevention subpopulation (ZOL, n = 144; RIS, n = 144) ≤3 months, treatment subpopulation (ZOL, n = 272; RIS, n = 273) >3 months]. Changes in β-C-terminal telopeptides of type 1 collagen (b-CTx), N-terminal telopeptide of type I collagen (NTx), procollagen type 1 N-terminal propeptide (P1NP) and bone-specific alkaline phosphatase (BSAP) from baseline were measured on day 10 and months 3, 6 and 12. Results: At most time points, there were significantly greater reductions (P<0.05) in the concentrations of serum β-CTx, P1NP and BSAP and urine NTx in subjects on ZOL compared with RIS in both males and females of the treatment and prevention subpopulations. In pre- and post-menopausal women, there were significantly greater reductions in the concentrations of BTMs with ZOL compared with RIS. At 12 months, ZOL had significantly greater reductions compared with RIS (P<0.05) for β-CTx, P1NP, BSAP and NTx levels, independent of glucocorticoid dose. Conclusions: Once-yearly i.v. infusion of ZOL 5mg was well tolerated in different subgroups of GIO patients. ZOL was non-inferior to RIS and even superior to RIS in the response of BTMs in GIO patients.
AB - Objective: Long-term glucocorticoid use is accompanied by rapid bone loss; however, early treatment with bisphosphonates prevents bone loss and reduces fracture risk. The aim of this study was to examine the effects of two bisphosphonates, i.v. zoledronic acid (ZOL) versus oral risedronate (RIS), on bone turnover markers (BTMs) in subjects with glucocorticoid-induced osteoporosis (GIO). Methods: Patients were randomly stratified according to the duration of pre-study glucocorticoid therapy [prevention subpopulation (ZOL, n = 144; RIS, n = 144) ≤3 months, treatment subpopulation (ZOL, n = 272; RIS, n = 273) >3 months]. Changes in β-C-terminal telopeptides of type 1 collagen (b-CTx), N-terminal telopeptide of type I collagen (NTx), procollagen type 1 N-terminal propeptide (P1NP) and bone-specific alkaline phosphatase (BSAP) from baseline were measured on day 10 and months 3, 6 and 12. Results: At most time points, there were significantly greater reductions (P<0.05) in the concentrations of serum β-CTx, P1NP and BSAP and urine NTx in subjects on ZOL compared with RIS in both males and females of the treatment and prevention subpopulations. In pre- and post-menopausal women, there were significantly greater reductions in the concentrations of BTMs with ZOL compared with RIS. At 12 months, ZOL had significantly greater reductions compared with RIS (P<0.05) for β-CTx, P1NP, BSAP and NTx levels, independent of glucocorticoid dose. Conclusions: Once-yearly i.v. infusion of ZOL 5mg was well tolerated in different subgroups of GIO patients. ZOL was non-inferior to RIS and even superior to RIS in the response of BTMs in GIO patients.
KW - Bone turnover markers
KW - Glucocorticoid-induced osteoporosis
KW - Glucocorticoids
KW - Risedronate
KW - Zoledronic acid
UR - http://www.scopus.com/inward/record.url?scp=84878143064&partnerID=8YFLogxK
U2 - 10.1093/rheumatology/kes410
DO - 10.1093/rheumatology/kes410
M3 - Article
C2 - 23365149
AN - SCOPUS:84878143064
SN - 1462-0324
VL - 52
SP - 1058
EP - 1069
JO - Rheumatology (United Kingdom)
JF - Rheumatology (United Kingdom)
IS - 6
ER -