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Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis.
N Engl J Med. 2007 May 03; 356(18):1809-22.NEJM

Abstract

BACKGROUND

A single infusion of intravenous zoledronic acid decreases bone turnover and improves bone density at 12 months in postmenopausal women with osteoporosis. We assessed the effects of annual infusions of zoledronic acid on fracture risk during a 3-year period.

METHODS

In this double-blind, placebo-controlled trial, 3889 patients (mean age, 73 years) were randomly assigned to receive a single 15-minute infusion of zoledronic acid (5 mg) and 3876 were assigned to receive placebo at baseline, at 12 months, and at 24 months; the patients were followed until 36 months. Primary end points were new vertebral fracture (in patients not taking concomitant osteoporosis medications) and hip fracture (in all patients). Secondary end points included bone mineral density, bone turnover markers, and safety outcomes.

RESULTS

Treatment with zoledronic acid reduced the risk of morphometric vertebral fracture by 70% during a 3-year period, as compared with placebo (3.3% in the zoledronic-acid group vs. 10.9% in the placebo group; relative risk, 0.30; 95% confidence interval [CI], 0.24 to 0.38) and reduced the risk of hip fracture by 41% (1.4% in the zoledronic-acid group vs. 2.5% in the placebo group; hazard ratio, 0.59; 95% CI, 0.42 to 0.83). Nonvertebral fractures, clinical fractures, and clinical vertebral fractures were reduced by 25%, 33%, and 77%, respectively (P<0.001 for all comparisons). Zoledronic acid was also associated with a significant improvement in bone mineral density and bone metabolism markers. Adverse events, including change in renal function, were similar in the two study groups. However, serious atrial fibrillation occurred more frequently in the zoledronic acid group (in 50 vs. 20 patients, P<0.001).

CONCLUSIONS

A once-yearly infusion of zoledronic acid during a 3-year period significantly reduced the risk of vertebral, hip, and other fractures. (ClinicalTrials.gov number, NCT00049829.)

Authors+Show Affiliations

University of California, San Francisco, San Francisco, CA 94107, USA. dblack@psg.ucsf.eduNo 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 availableNo 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 availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17476007

Citation

Black, Dennis M., et al. "Once-yearly Zoledronic Acid for Treatment of Postmenopausal Osteoporosis." The New England Journal of Medicine, vol. 356, no. 18, 2007, pp. 1809-22.
Black DM, Delmas PD, Eastell R, et al. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med. 2007;356(18):1809-22.
Black, D. M., Delmas, P. D., Eastell, R., Reid, I. R., Boonen, S., Cauley, J. A., Cosman, F., Lakatos, P., Leung, P. C., Man, Z., Mautalen, C., Mesenbrink, P., Hu, H., Caminis, J., Tong, K., Rosario-Jansen, T., Krasnow, J., Hue, T. F., Sellmeyer, D., ... Cummings, S. R. (2007). Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. The New England Journal of Medicine, 356(18), 1809-22.
Black DM, et al. Once-yearly Zoledronic Acid for Treatment of Postmenopausal Osteoporosis. N Engl J Med. 2007 May 3;356(18):1809-22. PubMed PMID: 17476007.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. AU - Black,Dennis M, AU - Delmas,Pierre D, AU - Eastell,Richard, AU - Reid,Ian R, AU - Boonen,Steven, AU - Cauley,Jane A, AU - Cosman,Felicia, AU - Lakatos,Péter, AU - Leung,Ping Chung, AU - Man,Zulema, AU - Mautalen,Carlos, AU - Mesenbrink,Peter, AU - Hu,Huilin, AU - Caminis,John, AU - Tong,Karen, AU - Rosario-Jansen,Theresa, AU - Krasnow,Joel, AU - Hue,Trisha F, AU - Sellmeyer,Deborah, AU - Eriksen,Erik Fink, AU - Cummings,Steven R, AU - ,, PY - 2007/5/4/pubmed PY - 2007/5/9/medline PY - 2007/5/4/entrez SP - 1809 EP - 22 JF - The New England journal of medicine JO - N Engl J Med VL - 356 IS - 18 N2 - BACKGROUND: A single infusion of intravenous zoledronic acid decreases bone turnover and improves bone density at 12 months in postmenopausal women with osteoporosis. We assessed the effects of annual infusions of zoledronic acid on fracture risk during a 3-year period. METHODS: In this double-blind, placebo-controlled trial, 3889 patients (mean age, 73 years) were randomly assigned to receive a single 15-minute infusion of zoledronic acid (5 mg) and 3876 were assigned to receive placebo at baseline, at 12 months, and at 24 months; the patients were followed until 36 months. Primary end points were new vertebral fracture (in patients not taking concomitant osteoporosis medications) and hip fracture (in all patients). Secondary end points included bone mineral density, bone turnover markers, and safety outcomes. RESULTS: Treatment with zoledronic acid reduced the risk of morphometric vertebral fracture by 70% during a 3-year period, as compared with placebo (3.3% in the zoledronic-acid group vs. 10.9% in the placebo group; relative risk, 0.30; 95% confidence interval [CI], 0.24 to 0.38) and reduced the risk of hip fracture by 41% (1.4% in the zoledronic-acid group vs. 2.5% in the placebo group; hazard ratio, 0.59; 95% CI, 0.42 to 0.83). Nonvertebral fractures, clinical fractures, and clinical vertebral fractures were reduced by 25%, 33%, and 77%, respectively (P<0.001 for all comparisons). Zoledronic acid was also associated with a significant improvement in bone mineral density and bone metabolism markers. Adverse events, including change in renal function, were similar in the two study groups. However, serious atrial fibrillation occurred more frequently in the zoledronic acid group (in 50 vs. 20 patients, P<0.001). CONCLUSIONS: A once-yearly infusion of zoledronic acid during a 3-year period significantly reduced the risk of vertebral, hip, and other fractures. (ClinicalTrials.gov number, NCT00049829.) SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/17476007/Once_yearly_zoledronic_acid_for_treatment_of_postmenopausal_osteoporosis_ L2 - https://www.nejm.org/doi/10.1056/NEJMoa067312?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -