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Effect of once-yearly zoledronic acid five milligrams on fracture risk and change in femoral neck bone mineral density.
J Clin Endocrinol Metab. 2009 Sep; 94(9):3215-25.JC

Abstract

CONTEXT

In the Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly - Pivotal Fracture Trial (HORIZON-PFT), zoledronic acid (ZOL) 5 mg significantly reduced fracture risk.

OBJECTIVE

The aim of the study was to identify factors associated with greater efficacy during ZOL 5 mg treatment.

DESIGN, SETTING, AND PATIENTS

We conducted a subgroup analysis (preplanned and post hoc) of a multicenter, double-blind, placebo-controlled, 36-month trial in 7765 women with postmenopausal osteoporosis.

INTERVENTION

A single infusion of ZOL 5 mg or placebo was administered at baseline, 12, and 24 months.

MAIN OUTCOME MEASURES

Primary endpoints were new vertebral fracture and hip fracture. Secondary endpoints were nonvertebral fracture and change in femoral neck bone mineral density (BMD). Baseline risk factor subgroups were age, BMD T-score and vertebral fracture status, total hip BMD, race, weight, geographical region, smoking, height loss, history of falls, physical activity, prior bisphosphonates, creatinine clearance, body mass index, and concomitant osteoporosis medications.

RESULTS

Greater ZOL induced effects on vertebral fracture risk were seen with younger age (treatment-by-subgroup interaction, P = 0.05), normal creatinine clearance (P = 0.04), and body mass index >or= 25 kg/m(2) (P = 0.02). There were no significant treatment-factor interactions for hip or nonvertebral fracture or for change in BMD.

CONCLUSIONS

ZOL appeared more effective in preventing vertebral fracture in younger women, overweight/obese women, and women with normal renal function. ZOL had similar effects irrespective of fracture risk factors or femoral neck BMD.

Authors+Show Affiliations

Academic Unit of Bone Metabolism, Metabolic Bone Centre, Sorby Wing, Northern General Hospital, Herries Road, Sheffield, South Yorkshire S5 7AU, United Kingdom. r.eastell@sheffield.ac.ukNo 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

Language

eng

PubMed ID

19567517

Citation

Eastell, Richard, et al. "Effect of Once-yearly Zoledronic Acid Five Milligrams On Fracture Risk and Change in Femoral Neck Bone Mineral Density." The Journal of Clinical Endocrinology and Metabolism, vol. 94, no. 9, 2009, pp. 3215-25.
Eastell R, Black DM, Boonen S, et al. Effect of once-yearly zoledronic acid five milligrams on fracture risk and change in femoral neck bone mineral density. J Clin Endocrinol Metab. 2009;94(9):3215-25.
Eastell, R., Black, D. M., Boonen, S., Adami, S., Felsenberg, D., Lippuner, K., Cummings, S. R., Delmas, P. D., Palermo, L., Mesenbrink, P., & Cauley, J. A. (2009). Effect of once-yearly zoledronic acid five milligrams on fracture risk and change in femoral neck bone mineral density. The Journal of Clinical Endocrinology and Metabolism, 94(9), 3215-25. https://doi.org/10.1210/jc.2008-2765
Eastell R, et al. Effect of Once-yearly Zoledronic Acid Five Milligrams On Fracture Risk and Change in Femoral Neck Bone Mineral Density. J Clin Endocrinol Metab. 2009;94(9):3215-25. PubMed PMID: 19567517.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of once-yearly zoledronic acid five milligrams on fracture risk and change in femoral neck bone mineral density. AU - Eastell,Richard, AU - Black,Dennis M, AU - Boonen,Steven, AU - Adami,Silvano, AU - Felsenberg,Dieter, AU - Lippuner,Kurt, AU - Cummings,Steven R, AU - Delmas,Pierre D, AU - Palermo,Lisa, AU - Mesenbrink,Peter, AU - Cauley,Jane A, AU - ,, Y1 - 2009/06/30/ PY - 2009/7/2/entrez PY - 2009/7/2/pubmed PY - 2009/9/24/medline SP - 3215 EP - 25 JF - The Journal of clinical endocrinology and metabolism JO - J Clin Endocrinol Metab VL - 94 IS - 9 N2 - CONTEXT: In the Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly - Pivotal Fracture Trial (HORIZON-PFT), zoledronic acid (ZOL) 5 mg significantly reduced fracture risk. OBJECTIVE: The aim of the study was to identify factors associated with greater efficacy during ZOL 5 mg treatment. DESIGN, SETTING, AND PATIENTS: We conducted a subgroup analysis (preplanned and post hoc) of a multicenter, double-blind, placebo-controlled, 36-month trial in 7765 women with postmenopausal osteoporosis. INTERVENTION: A single infusion of ZOL 5 mg or placebo was administered at baseline, 12, and 24 months. MAIN OUTCOME MEASURES: Primary endpoints were new vertebral fracture and hip fracture. Secondary endpoints were nonvertebral fracture and change in femoral neck bone mineral density (BMD). Baseline risk factor subgroups were age, BMD T-score and vertebral fracture status, total hip BMD, race, weight, geographical region, smoking, height loss, history of falls, physical activity, prior bisphosphonates, creatinine clearance, body mass index, and concomitant osteoporosis medications. RESULTS: Greater ZOL induced effects on vertebral fracture risk were seen with younger age (treatment-by-subgroup interaction, P = 0.05), normal creatinine clearance (P = 0.04), and body mass index >or= 25 kg/m(2) (P = 0.02). There were no significant treatment-factor interactions for hip or nonvertebral fracture or for change in BMD. CONCLUSIONS: ZOL appeared more effective in preventing vertebral fracture in younger women, overweight/obese women, and women with normal renal function. ZOL had similar effects irrespective of fracture risk factors or femoral neck BMD. SN - 1945-7197 UR - https://www.unboundmedicine.com/medline/citation/19567517/Effect_of_once_yearly_zoledronic_acid_five_milligrams_on_fracture_risk_and_change_in_femoral_neck_bone_mineral_density_ L2 - https://academic.oup.com/jcem/article-lookup/doi/10.1210/jc.2008-2765 DB - PRIME DP - Unbound Medicine ER -