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Effect on bone turnover markers of once-yearly intravenous infusion of zoledronic acid versus daily oral risedronate in patients treated with glucocorticoids.
Rheumatology (Oxford). 2013 Jun; 52(6):1058-69.R

Abstract

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 (β-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 5 mg 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.

TRIAL REGISTRATION

ClinicalTrials.gov, http://clinicaltrials.gov, NCT00100620.

Authors+Show Affiliations

Université Catholique de Louvain, UCL5390, B-1200 Brussels, Belgium. devogelaer@ruma.ucl.ac.beNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23365149

Citation

Devogelaer, Jean-Pierre, et al. "Effect On Bone Turnover Markers of Once-yearly Intravenous Infusion of Zoledronic Acid Versus Daily Oral Risedronate in Patients Treated With Glucocorticoids." Rheumatology (Oxford, England), vol. 52, no. 6, 2013, pp. 1058-69.
Devogelaer JP, Sambrook P, Reid DM, et al. Effect on bone turnover markers of once-yearly intravenous infusion of zoledronic acid versus daily oral risedronate in patients treated with glucocorticoids. Rheumatology (Oxford). 2013;52(6):1058-69.
Devogelaer, J. P., Sambrook, P., Reid, D. M., Goemaere, S., Ish-Shalom, S., Collette, J., Su, G., Bucci-Rechtweg, C., Papanastasiou, P., & Reginster, J. Y. (2013). Effect on bone turnover markers of once-yearly intravenous infusion of zoledronic acid versus daily oral risedronate in patients treated with glucocorticoids. Rheumatology (Oxford, England), 52(6), 1058-69. https://doi.org/10.1093/rheumatology/kes410
Devogelaer JP, et al. Effect On Bone Turnover Markers of Once-yearly Intravenous Infusion of Zoledronic Acid Versus Daily Oral Risedronate in Patients Treated With Glucocorticoids. Rheumatology (Oxford). 2013;52(6):1058-69. PubMed PMID: 23365149.
* Article titles in AMA citation format should be in sentence-case
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, Y1 - 2013/01/30/ PY - 2013/2/1/entrez PY - 2013/2/1/pubmed PY - 2013/7/23/medline KW - bone turnover markers KW - glucocorticoid-induced osteoporosis KW - glucocorticoids KW - risedronate KW - zoledronic acid SP - 1058 EP - 69 JF - Rheumatology (Oxford, England) JO - Rheumatology (Oxford) VL - 52 IS - 6 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 (β-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 5 mg 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. TRIAL REGISTRATION: ClinicalTrials.gov, http://clinicaltrials.gov, NCT00100620. SN - 1462-0332 UR - https://www.unboundmedicine.com/medline/citation/23365149/Effect_on_bone_turnover_markers_of_once_yearly_intravenous_infusion_of_zoledronic_acid_versus_daily_oral_risedronate_in_patients_treated_with_glucocorticoids_ L2 - https://academic.oup.com/rheumatology/article-lookup/doi/10.1093/rheumatology/kes410 DB - PRIME DP - Unbound Medicine ER -