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MULTINATIONAL, MULTICENTRIC, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY, IN PARALLEL GROUPS, TO EVALUATE THE EFFICACY OF ZOLEDRONIC ACID ADMINSTRATED BY INTRAVENOUS VIA IN THE PREVENTION OF OSTEOPOROTIC FRACTURES AFTER A HIP FRACTURE.

MULTINATIONAL, MULTICENTRIC, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY, IN PARALLEL GROUPS, TO EVALUATE THE EFFICACY OF ZOLEDRONIC ACID ADMINSTRATED BY INTRAVENOUS VIA IN THE PREVENTION OF OSTEOPOROTIC FRACTURES AFTER A HIP FRACTURE.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-061-02
Enrollment
Unknown
Registered
2002-10-10
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

None listed

Interventions

PLACEBO Type of group
Placebo of zoledronic acid 5 mg intravenously in a 15-minute infusion will be administered. Group name:Zoledronic acid Type of group
An intravenous infusion of zoledronic acid (5 mg i.v. for 15 minutes) will be administered.

Sponsors

NOVARTIS BIOSCIENSES PERU S.A.,
Lead Sponsor

Eligibility

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
Outcome name:Time to the first fracture. Measure:Time from randomization to a first clinical fracture. Timepoints:6 weeks—

Secondary

MeasureTime frame
Outcome name:bone mineral density Measure:Percentage change in total bone mineral density (BMD) in the hip, as measured by dual X-ray absorptiometry (DXA) of the non-fractured hip, at 24 months compared to 6-weeks post-infusion. Timepoints:24 month—

Countries

Germany, Peru, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)