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

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. Identifier: NCT00046254
Recruitment Status : Completed
First Posted : September 25, 2002
Last Update Posted : May 2, 2012
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoporosis Hip Fracture Drug: Zoledronic Acid Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 2127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : February 2002
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Significant reduction in rate of clinical fractures after surgical repair of hip fracture

Secondary Outcome Measures :
  1. Increase in total hip and femoral neck BMDs

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00046254

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Sponsors and Collaborators
Novartis Pharmaceuticals
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00046254    
Other Study ID Numbers: CZOL446H2310
First Posted: September 25, 2002    Key Record Dates
Last Update Posted: May 2, 2012
Last Verified: May 2012
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
hip fracture
recurrent fracture
bone loss
bone mineral density
zoledronic acid
nursing home
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Femoral Fractures
Hip Injuries
Leg Injuries
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs