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HORIZON-PFT: Pivotal Fracture Trial

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ClinicalTrials.gov Identifier: NCT00049829
Recruitment Status : Completed
First Posted : November 15, 2002
Last Update Posted : November 2, 2011
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Osteoporosis Drug: Zoledronic Acid Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 7700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: HORIZON-PFT: Pivotal Fracture Trial
Study Start Date : January 2002
Actual Primary Completion Date : June 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Incidence of hip fxs
  2. Incidence of new vertebral fxs

Secondary Outcome Measures :
  1. Percent change in hip BMD
  2. New and/or worsening vertebral fxs
  3. All clinical fxs

Eligibility Criteria
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Ages Eligible for Study:   65 Years to 89 Years   (Older Adult)
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
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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


Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00049829    
Other Study ID Numbers: CZOL446H2301
First Posted: November 15, 2002    Key Record Dates
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:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
 Metabolic Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs