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

Novartis

Status and phase: Completed; Phase 3

Conditions: Osteoporosis; Hip Fracture

Treatments: Drug: Zoledronic Acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00046254

CZOL446H2310

Details and patient eligibility

About

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.

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind