Trials / Completed
CompletedNCT02771860
RANKL-blockade for the Treatment of Erosive Osteoarthritis (OA) of Interphalangeal Finger Joints
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- University Hospital, Ghent · Academic / Other
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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 the Ghent University Score System (GUSS). 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 dual energy x-ray absorptiometry parameters.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | denosumab | 60mg sc |
| DRUG | Placebo | identical syringe |
| DIETARY_SUPPLEMENT | Calcium/Vit D supplementation | Daily dosage Calcium 1000mg / Vit D 880 IU |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2019-06-26
- Completion
- 2021-04-28
- First posted
- 2016-05-13
- Last updated
- 2024-09-25
- Results posted
- 2024-09-25
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT02771860. Inclusion in this directory is not an endorsement.