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Completed

NCT Number: NCT00049829

HORIZON-PFT: Pivotal Fracture Trial

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

65 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Novartis, Nuremberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zoledronic acid

Drug

Primary outcomes

  1. Incidence of hip fxs

  2. Incidence of new vertebral fxs

Secondary outcomes

  1. Percent change in hip BMD

  2. New and/or worsening vertebral fxs

  3. All clinical fxs

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Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2002
Primary completion
2006
First posted
Nov 15, 2002
Registry last updated
Nov 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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