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Efficacy and safety of a once-yearly i.v. Infusion of zoledronic acid 5 mg versus a once-weekly 70-mg oral alendronate in the treatment of male osteoporosis: a randomized, multicenter, double-blind, active-controlled study.
J Bone Miner Res. 2010 Oct; 25(10):2239-50.JB

Abstract

Zoledronic acid (ZOL) has shown beneficial effects on bone turnover and bone mineral density (BMD) in postmenopausal osteoporosis. This study compared the efficacy and safety of a once-yearly i.v. infusion of ZOL with weekly oral alendronate (ALN) in men with osteoporosis. In this multicenter, double-blind, active-controlled, parallel-group study, participants (n = 302) were randomized to receive either once-yearly ZOL 5 mg i.v. or weekly oral ALN 70 mg for 24 months. Changes in BMD and bone marker levels were assessed. ZOL increased BMD at the lumbar spine, total hip, femoral neck, and trochanter and was not inferior to ALN at 24 months [least squares mean estimates of the percentage increases in lumbar spine BMD of 6.1% and 6.2%; difference approximately 0.13; 95% confidence interval (CI) 1.12-0.85 in the ZOL and ALN groups, respectively]. At month 12, the median change from baseline of markers for bone resorption [serum β-C-terminal telopeptide of type I collagen (β-CTx) and urine N-terminal telopeptide of type I collagen (NTx)] and formation [serum N-terminal propeptide of type I collagen (P1NP) and serum bone-specific alkaline phosphatase (BSAP)] were comparable between ZOL and ALN groups. Most men preferred i.v. ZOL over oral ALN. The incidence of adverse events and serious adverse events was similar in the treatment groups. It is concluded that a once-yearly i.v. infusion of ZOL 5 mg increased bone density and decreased bone turnover markers similarly to once-weekly oral ALN 70 mg in men with low bone density.

Authors+Show Affiliations

Oregon Health Sciences University, Portland, OR 97239, USA.No 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)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

20499357

Citation

Orwoll, Eric S., et al. "Efficacy and Safety of a Once-yearly I.v. Infusion of Zoledronic Acid 5 Mg Versus a Once-weekly 70-mg Oral Alendronate in the Treatment of Male Osteoporosis: a Randomized, Multicenter, Double-blind, Active-controlled Study." Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research, vol. 25, no. 10, 2010, pp. 2239-50.
Orwoll ES, Miller PD, Adachi JD, et al. Efficacy and safety of a once-yearly i.v. Infusion of zoledronic acid 5 mg versus a once-weekly 70-mg oral alendronate in the treatment of male osteoporosis: a randomized, multicenter, double-blind, active-controlled study. J Bone Miner Res. 2010;25(10):2239-50.
Orwoll, E. S., Miller, P. D., Adachi, J. D., Brown, J., Adler, R. A., Kendler, D., Bucci-Rechtweg, C., Readie, A., Mesenbrink, P., & Weinstein, R. S. (2010). Efficacy and safety of a once-yearly i.v. Infusion of zoledronic acid 5 mg versus a once-weekly 70-mg oral alendronate in the treatment of male osteoporosis: a randomized, multicenter, double-blind, active-controlled study. Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research, 25(10), 2239-50. https://doi.org/10.1002/jbmr.119
Orwoll ES, et al. Efficacy and Safety of a Once-yearly I.v. Infusion of Zoledronic Acid 5 Mg Versus a Once-weekly 70-mg Oral Alendronate in the Treatment of Male Osteoporosis: a Randomized, Multicenter, Double-blind, Active-controlled Study. J Bone Miner Res. 2010;25(10):2239-50. PubMed PMID: 20499357.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of a once-yearly i.v. Infusion of zoledronic acid 5 mg versus a once-weekly 70-mg oral alendronate in the treatment of male osteoporosis: a randomized, multicenter, double-blind, active-controlled study. AU - Orwoll,Eric S, AU - Miller,Paul D, AU - Adachi,Jonathan D, AU - Brown,Jacques, AU - Adler,Robert A, AU - Kendler,David, AU - Bucci-Rechtweg,Christina, AU - Readie,Aimee, AU - Mesenbrink,Peter, AU - Weinstein,Robert S, PY - 2010/5/26/entrez PY - 2010/5/26/pubmed PY - 2011/2/11/medline SP - 2239 EP - 50 JF - Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research JO - J Bone Miner Res VL - 25 IS - 10 N2 - Zoledronic acid (ZOL) has shown beneficial effects on bone turnover and bone mineral density (BMD) in postmenopausal osteoporosis. This study compared the efficacy and safety of a once-yearly i.v. infusion of ZOL with weekly oral alendronate (ALN) in men with osteoporosis. In this multicenter, double-blind, active-controlled, parallel-group study, participants (n = 302) were randomized to receive either once-yearly ZOL 5 mg i.v. or weekly oral ALN 70 mg for 24 months. Changes in BMD and bone marker levels were assessed. ZOL increased BMD at the lumbar spine, total hip, femoral neck, and trochanter and was not inferior to ALN at 24 months [least squares mean estimates of the percentage increases in lumbar spine BMD of 6.1% and 6.2%; difference approximately 0.13; 95% confidence interval (CI) 1.12-0.85 in the ZOL and ALN groups, respectively]. At month 12, the median change from baseline of markers for bone resorption [serum β-C-terminal telopeptide of type I collagen (β-CTx) and urine N-terminal telopeptide of type I collagen (NTx)] and formation [serum N-terminal propeptide of type I collagen (P1NP) and serum bone-specific alkaline phosphatase (BSAP)] were comparable between ZOL and ALN groups. Most men preferred i.v. ZOL over oral ALN. The incidence of adverse events and serious adverse events was similar in the treatment groups. It is concluded that a once-yearly i.v. infusion of ZOL 5 mg increased bone density and decreased bone turnover markers similarly to once-weekly oral ALN 70 mg in men with low bone density. SN - 1523-4681 UR - https://www.unboundmedicine.com/medline/citation/20499357/Efficacy_and_safety_of_a_once_yearly_i_v__Infusion_of_zoledronic_acid_5_mg_versus_a_once_weekly_70_mg_oral_alendronate_in_the_treatment_of_male_osteoporosis:_a_randomized_multicenter_double_blind_active_controlled_study_ L2 - https://doi.org/10.1002/jbmr.119 DB - PRIME DP - Unbound Medicine ER -