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RANKL-blockade for the Treatment of Erosive Osteoarthritis (OA) of Interphalangeal Finger Joints

NCT02771860 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-09-25

Study results available
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Summary

This is a randomized, double blind placebo controlled one-site proof-of-concept study in subjects with erosive osteoarthritis (OA) of interphalangeal (IP) finger joints.

A total of 100 subjects will be enrolled into the study: 48 weeks placebo controlled double-blind phase with denosumab 60mg every 12 weeks, followed by a 48-week open-label phase in which all subjects will receive denosumab.

Conditions

  • Hand Osteoarthritis

Interventions

DRUG

denosumab

60mg sc

DRUG

Placebo

identical syringe

DIETARY_SUPPLEMENT

Calcium/Vit D supplementation

Daily dosage Calcium 1000mg / Vit D 880 IU

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Dirk Elewaut, Prof. Dr. · UZ Ghent

  • August Verbruggen, Prof Dr. Em. · UZ Ghent

  • Ruth Wittoek, Prof. Dr. · UZ Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2019-06-26
Completion
2021-04-28

Countries

  • Belgium

Study Locations

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Entities

Drugs
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 NCT02771860 on ClinicalTrials.gov