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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
History of Changes
  Purpose

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 Intervention Phase
Osteoporosis
Hip Fracture
 Drug: Zoledronic Acid
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

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

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

Estimated Enrollment: 2127
Study Start Date: February 2002
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00046254

  Show 28 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00046254     History of Changes
Other Study ID Numbers: CZOL446H2310
Study First Received: September 24, 2002
Last Updated: May 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
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
Hip Fractures
Osteoporosis
Osteoporotic Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
 Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013