Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis; Weight Maintenance

Phase 4

Completed

• Conditions: Osteoarthritis; Obesity
• Interventions: Drug: Liraglutide 3 mg placebo; Drug: Liraglutide 3 mg (Saxenda)

• Registration Number: NCT02928679
• Lead Sponsor: Henrik Gudbergsen

Brief Summary

This is a substudy to a randomised trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counseling, after which patients will be randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle.

This substudy aims to investigate the impact of, and subsequent change of, joint inflammation, articular cartilage composition, overall knee morphology, and clinical symptoms, in obese patients with knee osteoarthritis following a randomisation to Liraglutide 3 mg or Liraglutide 3 mg placebo treatment between weeks 0-52.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-07
• Study First Submitted QC: 2016-10-07
• Study First Posted: 2016-10-10
• Study Start: 2016-11
• Primary Completion: 2019-02-20
• Status Verified: 2019-03
• Study Completion: 2019-03-20
• Last Update Submitted: 2019-03-21
• Last Update Posted: 2019-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Same as parent trial (NCT02905864)

Further

Exclusion Criteria

• Same as parent trial (NCT02905864)
• Usual exclusion criteria for MRI (i.e. pacemakers etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liraglutide 3 mg placebo	Liraglutide 3 mg placebo	Arm description: Subjects will be up titrated to liraglutide 3 mg placebo QD and stay on that dose for the remainder of the 52-week drug intervention period. Drug: Liraglutide 3 mg placebo QD administered in a 6 mg/mL drug equivalent volumes, 3 mL pen for subcutaneous injection. Dose escalation scheme: Initial dosage of a 0.6 mg drug equivalent volume per day, escalated bi-weekly by an 0.6 mg drug equivalent volume per day to a 3 mg drug equivalent volume per day over a total of 8 weeks.
Liraglutide 3 mg	Liraglutide 3 mg (Saxenda)	Arm description: Subjects will be up titrated to liraglutide 3 mg QD and stay on that dose for the remainder of the 52-week drug intervention period. Drug: Liraglutide 3 mg QD administered in a 6 mg/mL, 3 mL pen for subcutaneous injection. Dose escalation scheme: Initial dosage of 0.6 mg per day, escalated bi-weekly by 0.6 mg to 3 mg per day over a total of 8 weeks.

Primary Outcome Measures

Name	Time	Method
Change in the degree of inflammation in the knee-joint (DCE-MRI)	Week 0 to 52	Change will be assessed via a dynamic contrast enhanced MRI evaluation of corpus hoffa (Ballegaard C et al. and Riis RG et al.)

Secondary Outcome Measures

Name	Time	Method
Change in the degree of inflammation in the knee-joint (CE-MRI)	Week 0 to 52	Change will be assessed via a static contrast enhanced MRI evaluation of the level of synovitis in the knee-joint (11 sites scored 0-2, ad modum Guermazi et al.)
Change in the degree of inflammation in the knee-joint (MRI)	Week 0 to 52	Change will be assessed via a conventional MRI evaluation of the level of synovitis and effusion (combined) in the knee-joint (MOAKS)
Change in cartilage composition	Week 0 to 52	Change will be assessed via T2-maps of cartilage in the weight-bearing parts of the knee-joint (ROI)
Change in bone marrow lesions	Week 0 to 52	Change will be assessed via the MRI knee scoring system MOAKS; BML sum-score

Trial Locations

Locations (1)

The Parker Institute and Department of Radiology at Bispebjerg and Frederiksberg Hospital; 🇩🇰 Frederiksberg, Capital Region, Denmark