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HORIZON-PFT: Pivotal Fracture Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00049829
First Posted: November 15, 2002
Last Update Posted: November 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: HORIZON-PFT: Pivotal Fracture Trial

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 89 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00049829


  Show 60 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00049829     History of Changes
Other Study ID Numbers: CZOL446H2301
First Submitted: November 14, 2002
First Posted: November 15, 2002
Last Update Posted: November 2, 2011
Last Verified: November 2011

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

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