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Denosumab in Enhancement of Bone Bonding of Hip Prosthesis in Postmenopausal Women

NCT01926158 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2018-04-30

No results posted yet for this study

Summary

This randomized clinical trial will evaluate the efficacy of an antiresorptive osteoporosis drug (denosumab) in prevention of periprosthetic bone loss and in promotion of implant osseointegration (bone bonding) in postmenopausal women after total hip replacement. The investigators assume that denosumab prevents periprosthetic bone loss and enhances bone bonding of the hip stem in postmenopausal women.

Conditions

  • Hip Osteoarthritis

Interventions

DRUG

Denosumb

Prefilled syringe of 1 mL denosumab solution

DRUG

Placebo (for denosumab)

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Turku University Hospital

    lead OTHER_GOV

Principal Investigators

  • Hannu T Aro, MD, PhD · Turku University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2017-02-04
Completion
2017-12-31
FDA Drug
Yes

Countries

  • Finland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01926158 on ClinicalTrials.gov