Evaluating the Ability of Zoledronic Acid to Reduce the Rate of Subsequent Osteoporotic Fractures After a Hip Fracture

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00046254
First received: September 24, 2002
Last updated: May 1, 2012
Last verified: May 2012

September 24, 2002
May 1, 2012
February 2002
February 2007   (final data collection date for primary outcome measure)
Significant reduction in rate of clinical fractures after surgical repair of hip fracture
Not Provided
Complete list of historical versions of study NCT00046254 on ClinicalTrials.gov Archive Site
Increase in total hip and femoral neck BMDs
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Not Provided
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Evaluating the Ability of Zoledronic Acid to Reduce the Rate of Subsequent Osteoporotic Fractures After a Hip Fracture
Not Provided

The purpose of this study is to evaluate whether zoledronic acid given once yearly for two years to men and women after surgical repair of a recent hip fracture will significantly reduce the rate of all re-occurring (new) osteoporotic fractures. All patients will receive vitamin D and calcium.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Osteoporosis
  • Hip Fracture
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
2127
February 2007
February 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female ages 50 years or older
  • Must have a recent hip fracture repair in the past 90 days
  • Must be able to walk with or without assistive device (for example, using a walker) prior to the hip fracture

Exclusion Criteria:

  • Current bisphosphonate users such as aredia (pamidronate), didronel (etidronate), fosamax (alendronate), actonel (residronate), skelid (tiludronate)

Other protocol-defined inclusion/exclusion criteria may apply.

Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT00046254
CZOL446H2310
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Not Provided
Novartis
May 2012

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