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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00046254
Enrollment
2127
Registered
2002-09-25
Start date
2002-02-28
Completion date
2007-02-28
Last updated
2012-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fracture, Osteoporosis

Keywords

hip fracture, recurrent fracture, fracture, bone loss, bisphosphonate, bone mineral density, osteoporosis, zoledronic acid, geriatrics, rehabilitation, elderly, nursing home, orthopedic

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.

Interventions

DRUGZoledronic Acid

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
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/

Design outcomes

Primary

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

Secondary

MeasureTime frame
Increase in total hip and femoral neck BMDs

Countries

Germany, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 6, 2026