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Efficacy and safety of a once-yearly intravenous zoledronic acid 5 mg for fracture prevention in elderly postmenopausal women with osteoporosis aged 75 and older.
J Am Geriatr Soc. 2010 Feb; 58(2):292-9.JA

Abstract

OBJECTIVES

To determine the efficacy of once-yearly intravenous zoledronic acid (ZOL) 5 mg in reducing risk of clinical vertebral, nonvertebral, and any clinical fractures in elderly osteoporotic postmenopausal women.

DESIGN

A post hoc subgroup analysis of pooled data from the Health Outcome and Reduced Incidence with Zoledronic Acid One Yearly (HORIZON) Pivotal Fracture Trial and the HORIZON Recurrent Fracture Trial.

SETTING

Multicenter, randomized, double-blind, placebo-controlled trials.

PARTICIPANTS

Postmenopausal women (aged > or =75) with documented osteoporosis (T-score < or =-2.5 at femoral neck or >/=1 prevalent vertebral or hip fracture) or a recent hip fracture.

INTERVENTION

Patients were randomized to receive an intravenous infusion of ZOL 5 mg (n=1,961) or placebo (n=1,926) at baseline and 12 and 24 months.

MEASUREMENTS

Primary endpoints were incidence of clinical vertebral and nonvertebral and any clinical fracture after treatment.

RESULTS

At 3 years, incidence of any clinical, clinical vertebral, and nonvertebral fracture were significantly lower in the ZOL group than in the placebo group (10.8% vs 16.6%, 1.1% vs 3.7%, and 9.9% vs 13.7%, respectively) (hazard ratio (HR)=0.65, 95% confidence interval (CI)=0.54-0.78, P<.001; HR=0.34, 95% CI=0.21-0.55, P<.001; and HR=0.73, 95% CI=0.60-0.90, P=.002, respectively). The incidence of hip fracture was lower with ZOL but did not reach statistical significance. The incidence rate of postdose adverse events were higher with ZOL, although the rate of serious adverse events and deaths was comparable between the two groups.

CONCLUSION

Once-yearly intravenous ZOL 5 mg was associated with a significant reduction in the risk of new clinical fractures (vertebral and nonvertebral) in elderly postmenopausal women with osteroporosis.

Authors+Show Affiliations

Leuven University Centre for Metabolic Bone Diseases and Division of Geriatric Medicine, University of Leuven, Leuven, Belgium. Boonen@uz.kuleuven.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 available

Pub Type(s)

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

Language

eng

PubMed ID

20070415

Citation

Boonen, Steven, et al. "Efficacy and Safety of a Once-yearly Intravenous Zoledronic Acid 5 Mg for Fracture Prevention in Elderly Postmenopausal Women With Osteoporosis Aged 75 and Older." Journal of the American Geriatrics Society, vol. 58, no. 2, 2010, pp. 292-9.
Boonen S, Black DM, Colón-Emeric CS, et al. Efficacy and safety of a once-yearly intravenous zoledronic acid 5 mg for fracture prevention in elderly postmenopausal women with osteoporosis aged 75 and older. J Am Geriatr Soc. 2010;58(2):292-9.
Boonen, S., Black, D. M., Colón-Emeric, C. S., Eastell, R., Magaziner, J. S., Eriksen, E. F., Mesenbrink, P., Haentjens, P., & Lyles, K. W. (2010). Efficacy and safety of a once-yearly intravenous zoledronic acid 5 mg for fracture prevention in elderly postmenopausal women with osteoporosis aged 75 and older. Journal of the American Geriatrics Society, 58(2), 292-9. https://doi.org/10.1111/j.1532-5415.2009.02673.x
Boonen S, et al. Efficacy and Safety of a Once-yearly Intravenous Zoledronic Acid 5 Mg for Fracture Prevention in Elderly Postmenopausal Women With Osteoporosis Aged 75 and Older. J Am Geriatr Soc. 2010;58(2):292-9. PubMed PMID: 20070415.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of a once-yearly intravenous zoledronic acid 5 mg for fracture prevention in elderly postmenopausal women with osteoporosis aged 75 and older. AU - Boonen,Steven, AU - Black,Dennis M, AU - Colón-Emeric,Cathleen S, AU - Eastell,Richard, AU - Magaziner,Jay S, AU - Eriksen,Erik Fink, AU - Mesenbrink,Peter, AU - Haentjens,Patrick, AU - Lyles,Kenneth W, Y1 - 2010/01/08/ PY - 2010/1/15/entrez PY - 2010/1/15/pubmed PY - 2010/4/23/medline SP - 292 EP - 9 JF - Journal of the American Geriatrics Society JO - J Am Geriatr Soc VL - 58 IS - 2 N2 - OBJECTIVES: To determine the efficacy of once-yearly intravenous zoledronic acid (ZOL) 5 mg in reducing risk of clinical vertebral, nonvertebral, and any clinical fractures in elderly osteoporotic postmenopausal women. DESIGN: A post hoc subgroup analysis of pooled data from the Health Outcome and Reduced Incidence with Zoledronic Acid One Yearly (HORIZON) Pivotal Fracture Trial and the HORIZON Recurrent Fracture Trial. SETTING: Multicenter, randomized, double-blind, placebo-controlled trials. PARTICIPANTS: Postmenopausal women (aged > or =75) with documented osteoporosis (T-score < or =-2.5 at femoral neck or >/=1 prevalent vertebral or hip fracture) or a recent hip fracture. INTERVENTION: Patients were randomized to receive an intravenous infusion of ZOL 5 mg (n=1,961) or placebo (n=1,926) at baseline and 12 and 24 months. MEASUREMENTS: Primary endpoints were incidence of clinical vertebral and nonvertebral and any clinical fracture after treatment. RESULTS: At 3 years, incidence of any clinical, clinical vertebral, and nonvertebral fracture were significantly lower in the ZOL group than in the placebo group (10.8% vs 16.6%, 1.1% vs 3.7%, and 9.9% vs 13.7%, respectively) (hazard ratio (HR)=0.65, 95% confidence interval (CI)=0.54-0.78, P<.001; HR=0.34, 95% CI=0.21-0.55, P<.001; and HR=0.73, 95% CI=0.60-0.90, P=.002, respectively). The incidence of hip fracture was lower with ZOL but did not reach statistical significance. The incidence rate of postdose adverse events were higher with ZOL, although the rate of serious adverse events and deaths was comparable between the two groups. CONCLUSION: Once-yearly intravenous ZOL 5 mg was associated with a significant reduction in the risk of new clinical fractures (vertebral and nonvertebral) in elderly postmenopausal women with osteroporosis. SN - 1532-5415 UR - https://www.unboundmedicine.com/medline/citation/20070415/Efficacy_and_safety_of_a_once_yearly_intravenous_zoledronic_acid_5_mg_for_fracture_prevention_in_elderly_postmenopausal_women_with_osteoporosis_aged_75_and_older_ L2 - https://doi.org/10.1111/j.1532-5415.2009.02673.x DB - PRIME DP - Unbound Medicine ER -