HORIZON-PFT: Pivotal Fracture Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00049829
First received: November 14, 2002
Last updated: November 1, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Drug: Zoledronic Acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: HORIZON-PFT: Pivotal Fracture Trial

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Incidence of hip fxs
  • Incidence of new vertebral fxs

Secondary Outcome Measures:
  • Percent change in hip BMD
  • New and/or worsening vertebral fxs
  • All clinical fxs

Estimated Enrollment: 7700
Study Start Date: January 2002
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   65 Years to 89 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049829

  Show 60 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00049829     History of Changes
Other Study ID Numbers: CZOL446H2301
Study First Received: November 14, 2002
Last Updated: November 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Bisphosphonate,BMD,Height loss, Hip protectors,HRT,
Osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Zoledronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014