At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 100 enrolled
Drug / intervention
denosumab +2 moredrug
Likely dose
denosumab 60mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 (IP) Finger Joints
In Brief
A Phase 2 clinical trial evaluating denosumab, Placebo, and 1 other intervention for Hand Osteoarthritis. Completed, enrolled 100 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHand Osteoarthritis
CountriesBelgium
CollaboratorsAmgen
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartMar 2016
First PostedMay 2016
Primary CompletionJun 2019
Study CompletionApr 2021
TodayJul 2026
First PostedMay 13, 2016
Enrollment StartMar 1, 2016
Primary CompletionJun 26, 2019
Study CompletionApr 28, 2021
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 10.1 years ago
Interventions
denosumabdrug
60mg sc
Placebodrug
identical syringe
Calcium/Vit D supplementationdietary
Daily dosage Calcium 1000mg / Vit D 880 IU