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Effects of Denosumab on Periprosthetic Bone After Total Hip Arthroplasty

NCT01630941 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2017-04-05

No results posted yet for this study

Summary

The primary objective is to study the effect of Denosumab on Bone Mineral Density, Standardised Uptake Value and bone metabolism in patients with total hip arthroplasty. The primary hypothesis is to demonstrate that Denosumab is superior to placebo.

Conditions

  • Osteoarthritis, Hip
  • Ambulation Difficulty

Interventions

DRUG

denosumab

Two doses of 60 mg in a solution of 1 ml, given as an subcutaneous injection with a 6 month interval

Sponsors & Collaborators

  • Hans Mallmin

    lead OTHER

Principal Investigators

  • Hans Mallmin, MD, PhD · Uppsala University

  • Nils Hailer, MD, PhD · Uppsala University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-07
Primary Completion
2017-01-16
Completion
2017-03-30

Countries

  • Sweden

Study Locations

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Entities

Drugs

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 NCT01630941 on ClinicalTrials.gov