Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2009 Sep;94(9):3215-25.
doi: 10.1210/jc.2008-2765. Epub 2009 Jun 30.

Effect of once-yearly zoledronic acid five milligrams on fracture risk and change in femoral neck bone mineral density

Richard Eastell  1 , Dennis M Black, Steven Boonen, Silvano Adami, Dieter Felsenberg, Kurt Lippuner, Steven R Cummings, Pierre D Delmas, Lisa Palermo, Peter Mesenbrink, Jane A Cauley; HORIZON Pivotal Fracture Trial
Collaborators, Affiliations
Multicenter Study

Effect of once-yearly zoledronic acid five milligrams on fracture risk and change in femoral neck bone mineral density

Richard Eastell et al. J Clin Endocrinol Metab. 2009 Sep.

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.

Trial registration: ClinicalTrials.gov NCT00049829.

PubMed Disclaimer

Figures

FIG. 1
FIG. 1
Effect of baseline risk factors on reduction in vertebral fracture with zoledronic acid 5 mg at 3 yr in stratum I. OP, Osteoporosis (femoral neck T-score ≤−2.5); VFx, vertebral fracture; BP, bisphosphonate; CrCl, creatinine clearance; ZOL, zoledronic acid; CI, confidence interval. *, Vertebral fracture risk was assessed in the stratum I modified intent-to-treat population.
FIG. 2
FIG. 2
Effect of baseline risk factors on reduction in hip fracture with zoledronic acid 5 mg at 3 yr (strata I and II). OP, Osteoporosis (femoral neck T-score ≤−2.5); VFx, vertebral fracture; BP, bisphosphonate; CrCl, creatinine clearance; ZOL, zoledronic acid; CI, confidence interval.
FIG. 3
FIG. 3
Effect of baseline risk factors on reduction in nonvertebral fracture with zoledronic acid 5 mg at 3 yr (strata I and II). OP, Osteoporosis (femoral neck T-score ≤−2.5); VFx, vertebral fracture; BP, bisphosphonate; CrCl, creatinine clearance; ZOL, zoledronic acid; CI, confidence interval.
See this image and copyright information in PMC

References

    1. Reid IR, Brown JP, Burckhardt P, Horowitz Z, Richardson P, Trechsel U, Widmer A, Devogelaer JP, Kaufman JM, Jaeger P, Body JJ, Brandi ML, Broell J, Di Micco R, Genazzani AR, Felsenberg D, Happ J, Hooper MJ, Ittner J, Leb G, Mallmin H, Murray T, Ortolani S, Rubinacci A, Saaf M, Samsioe G, Verbruggen L, Meunier PJ. Intravenous zoledronic acid in postmenopausal women with low bone mineral density. N Engl J Med. 2002;346:653–661. - PubMed
    1. Black DM, Delmas PD, Eastell R, Reid IR, Boonen S, Cauley JA, Cosman F, Lakatos P, Leung PC, Man Z, Mautalen C, Mesenbrink P, Hu H, Caminis J, Tong K, Rosario-Jansen T, Krasnow J, Hue TF, Sellmeyer D, Eriksen EF, Cummings SR. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med. 2007;356:1809–1822. - PubMed
    1. Jones G, Nguyen T, Sambrook P, Kelly PJ, Eisman JA. Progressive loss of bone in the femoral neck in elderly people: longitudinal findings from the Dubbo osteoporosis epidemiology study. BMJ. 1994;309:691–695. - PMC - PubMed
    1. Boonen S, McClung MR, Eastell R, El-Hajj Fuleihan G, Barton IP, Delmas P. Safety and efficacy of risedronate in reducing fracture risk in osteoporotic women aged 80 and older: implications for the use of antiresorptive agents in the old and oldest old. J Am Geriatr Soc. 2004;52:1832–1839. - PubMed
    1. Boonen S, Marin F, Mellstrom D, Xie L, Desaiah D, Krege JH, Rosen CJ. Safety and efficacy of teriparatide in elderly women with established osteoporosis: bone anabolic therapy from a geriatric perspective. J Am Geriatr Soc. 2006;54:782–789. - PubMed

Publication types

Associated data

Grants and funding