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

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Femoral Fractures Fractures, Bone Hip Fracture Hip Fractures Hip Injuries Leg Injuries Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Wounds and Injuries

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis, Nuremberg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zoledronic acid

Drug

Primary outcomes

Significant reduction in rate of clinical fractures after surgical repair of hip fracture

Secondary outcomes

Increase in total hip and femoral neck BMDs

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start: 2002
Primary completion: 2007
Study completion: 2007
First posted: Sep 25, 2002
Registry last updated: May 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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