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

November 14, 2002
November 1, 2011
January 2002
June 2006   (final data collection date for primary outcome measure)
  • Incidence of hip fxs
  • Incidence of new vertebral fxs
Not Provided
Complete list of historical versions of study NCT00049829 on ClinicalTrials.gov Archive Site
  • Percent change in hip BMD
  • New and/or worsening vertebral fxs
  • All clinical fxs
Not Provided
Not Provided
Not Provided
 
HORIZON-PFT: Pivotal Fracture Trial
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Osteoporosis
Drug: Zoledronic Acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7700
Not Provided
June 2006   (final data collection date for primary outcome measure)

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.

Female
65 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT00049829
CZOL446H2301
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Not Provided
Novartis
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP