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

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

Study Description
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

Study Design

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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

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.

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): NCT00046254


  Show 28 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: NCT00046254     History of Changes
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
fracture
bone loss
bisphosphonate
bone mineral density
osteoporosis
zoledronic acid
geriatrics
rehabilitation
elderly
nursing home
orthopedic

Additional relevant MeSH terms:
Fractures, Bone
Osteoporosis
Hip Fractures
Osteoporotic Fractures
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Femoral Fractures
Hip Injuries
Leg Injuries
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs