What side effects are associated with this type of intervention?

Common treatments for osteoarthritis (OA) include nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoid injections, and non-pharmacologic interventions such as weight management and physical therapy. NSAIDs can cause gastrointestinal issues (e.g., ulcers, bleeding), cardiovascular risks (e.g., heart attack, stroke), and renal problems. Glucocorticoid injections may lead to joint infection, increased pain, and potential cartilage damage with repeated use. Non-pharmacologic interventions like weight management and physical therapy generally have fewer side effects but require patient adherence and can be limited by individual physical capabilities.

What prior FDA approvals exist?

The FDA has approved several treatments for osteoarthritis, including nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and diclofenac, which are effective for pain relief. Intraarticular corticosteroids and hyaluronic acid injections are also used, though their long-term efficacy is debated. For patients with obesity, GLP-1 receptor agonists like liraglutide and semaglutide, which aid in weight management and have cardiovascular benefits, are relevant. These treatments align with the comprehensive approach of the Multidisciplinary Obesity Treatment Program, focusing on weight management and overall health improvement.

What other types of research exist?

Promising alternatives to a Multidisciplinary Obesity Treatment Program for OA patients include: 1) Disease-specific self-management programs like the Osteoarthritis of the Knee Self-Management Program (OAK), which has shown clinically meaningful improvements in health-related outcomes. 2) Stepped-care interventions, which involve a structured, progressive approach to treatment and have demonstrated effectiveness in disease remission rates. 3) Non-pharmacological multidisciplinary face-to-face or telephone-based treatment programs, which have been effective in improving daily function in patients with generalized osteoarthritis.

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OA Optimization Program for Osteoarthritis

Phase 1 & 2

Waitlist Available

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Symptomatic osteoarthritis referred to the Alberta Hip and Knee Clinic for assessment for total joint replacement surgery

Be older than 18 years old

Must not have

Diagnosed with type 1 diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a program where health experts help patients with obesity and severe osteoarthritis manage their weight and improve their health while they wait for joint replacement surgery. The goal is to provide comprehensive support to improve their overall well-being during the waiting period.

Who is the study for?

This trial is for individuals with a body mass index (BMI) over 30 and symptomatic osteoarthritis, who are awaiting joint replacement surgery. It's not suitable for those who can't read or speak English, use email or virtual platforms like Zoom, are pregnant or breastfeeding, have type 1 diabetes, or follow specialized diets.

What is being tested?

The trial tests if adding the Alberta Obesity Centre program to usual care helps people with obesity and osteoarthritis improve their health while waiting for surgery. Participants will receive either standard advice on weight management and activity or be part of an intensive multidisciplinary treatment program.

What are the potential side effects?

Since this trial involves lifestyle interventions such as diet advice and physiotherapy rather than medication, side effects may include muscle soreness from increased physical activity but typically do not involve drug-related risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have painful joint arthritis and am being evaluated for joint replacement surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with type 1 diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the number of adults with osteoarthritis and obesity that are eligible to participate in the trial

The characteristics of these adults with osteoarthritis and obesity who are willing to take part in the trial

The number and percentage of participants retained at 12-months

+1 more

Secondary study objectives

Change in blood lipid profile

Change in blood pressure

Change in body mass

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Alberta Obesity Centre ProgramExperimental Treatment3 Interventions

Evidence-based medical management of obesity using a multidisciplinary approach.

Group II: Alberta Healthy Living ProgramActive Control3 Interventions

An integrated community-based chronic disease management program available to residents of Alberta.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Physiotherapy

2014

Completed Phase 4

~4470

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Osteoarthritis (OA) include nonsteroidal anti-inflammatory drugs (NSAIDs), weight management, and physical activity. NSAIDs, such as ibuprofen and naproxen, work by reducing inflammation and pain in the joints, which helps improve mobility and quality of life. Weight management is crucial because excess weight puts additional stress on weight-bearing joints, exacerbating OA symptoms. A comprehensive approach to weight management, including dietary changes and physical activity, can reduce this stress, alleviate pain, and improve joint function. Physical activity strengthens the muscles around the joints, enhances flexibility, and reduces stiffness, contributing to overall joint health. These treatments are essential for OA patients as they address both the symptoms and underlying factors contributing to the disease, leading to better long-term outcomes.