HORIZON-PFT: Pivotal Fracture Trial

Overview

HORIZON-PFT (Pivotal Fracture Trial) will study the effect of zoledronic acid, given once per year, on the treatment of osteoporosis in women past menopause. Hip and vertebral fractures are the most devastating consequences of osteoporosis. HORIZON-PFT is designed to determine the benefits of zoledronic acid in fracture reduction at both the hip and spine.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: June 2006

Interventions

  • Drug: Zoledronic Acid

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of hip fxs
  • Incidence of new vertebral fxs

Secondary Measures

  • Percent change in hip BMD
  • New and/or worsening vertebral fxs
  • All clinical fxs

Participating in This Clinical Trial

Inclusion Criteria

  • Female, 65-89 years old
  • No history of severe liver, kidney or eye disease

Exclusion Criteria

  • Current bisphosphonate users such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel® (risedronate), Skelid® (tiludronate)
  • Using hip protectors

Other protocol-defined inclusion/exclusion criteria may apply.

Gender Eligibility: Female

Minimum Age: 65 Years

Maximum Age: 89 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor

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