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

Hand Osteoarthritis Clinical Trial

Official title: Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy of Denosumab 60mg sc Every 3 Months in Patients With Erosive Osteoarthritis of the Interphalangeal Finger Joints

Status Completed

Clinical Trial 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.

Clinical Trial Description

Investigational therapy: denosumab 60mg subcutaneous injection every 12 weeks. All subjects will receive Calcium/vit D supplementation.

Efficacy objectives:

The primary objective is to assess the effect of denosumab on the reduction of radiographic erosive progression using GUSS (Ghent University Score System).

The secondary objective is to assess the effect of denosumab on the reduction of radiographic erosive progression as defined by diminishing the appearance of new erosive IP finger joints.

The exploratory objective is mainly to assess the effect of denosumab on clinical variables, as well as ultrasonography and DEXA (dual energy x-ray absorptiometry) parameters. ;

Related Conditions & MeSH terms

• Hand Osteoarthritis
• Osteoarthritis

• NCT number: NCT02771860
• Study type: Interventional
• Source: University Hospital, Ghent
• Status: Completed
• Phase: Phase 2
• Start date: March 2016
• Completion date: April 28, 2021