What side effects are associated with this type of intervention?

Common treatments for osteoporosis include bisphosphonates, teriparatide, and denosumab. Bisphosphonates can cause gastrointestinal issues, musculoskeletal pain, and, rarely, osteonecrosis of the jaw and atypical femoral fractures. Teriparatide may lead to hypercalcemia and has a black box warning for osteosarcoma. Denosumab can cause hypocalcemia, skin infections, and an increased risk of vertebral fractures upon discontinuation. Lifestyle interventions like strength training and balance exercises generally have fewer side effects but may include muscle soreness or injury if not performed correctly.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of osteoporosis, including bisphosphonates like alendronate and risedronate, which are commonly used due to their efficacy in reducing fracture risk. Anabolic agents such as teriparatide are reserved for severe cases. Denosumab, a monoclonal antibody, is another option, particularly for those intolerant to bisphosphonates. These pharmacotherapies are often combined with non-pharmacological interventions like strength training, balance exercises, and nutritional counseling to improve functional mobility and bone strength, as explored in the Virtually-Delivered Gender-Tailored Intervention trial.

What other types of research exist?

Promising alternatives include: 1) Home-based trunk-strengthening exercise programs, which have shown benefits in spinal mobility, function, and quality of life for osteoporotic and osteopenic postmenopausal women. 2) Smartphone applications designed for osteoporosis prevention, which have demonstrated efficacy in improving bone mineral density and trabecular bone scores. 3) Teriparatide (PTH 1-34), an anabolic agent, particularly for patients with severe osteoporosis or those who have not responded to bisphosphonates. 4) Denosumab, a monoclonal antibody that inhibits bone resorption, as an alternative for those intolerant to bisphosphonates.

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Telehealth Intervention for Osteoporosis in Older Men (MisterFIt Trial)

N/A

Recruiting

Led By Suzanne Morin, MD

Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria Checklist

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

Must have

Fracture at any skeletal site (excluding skull, hands, and feet) within the previous 2 years

Community-dwelling individuals ≥ 60 years who self-identify as men with high risk for fracture

Must not have

Uncontrolled medical comorbidity including but not limited to congestive heart failure exacerbation in the last 12 months or COPD exacerbation in the last 3 months

Inability to communicate in English or French

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help older men at high risk of fractures by combining osteoporosis medication with online exercise and nutrition sessions. The medication strengthens bones, while the exercises and diet improve fitness and balance. The goal is to see if this combined approach can better prevent falls and improve mobility.

Who is the study for?

This trial is for community-dwelling men over 60 with a high risk of fractures, who have had previous fragility fractures or are on certain anti-osteoporosis medications. They must be able to communicate in English or French and have access to technology for telehealth. Men already doing similar exercises twice a week, unable to perform daily activities, or with severe cognitive issues cannot join.

What is being tested?

The study tests a virtual fracture prevention program tailored for older men at high risk of fractures against an attention control group. It includes gender-specific strength training, balance exercises, and nutritional counseling delivered online alongside standard anti-osteoporosis drugs.

What are the potential side effects?

Since the intervention primarily involves exercise and nutrition advice delivered virtually, side effects may include typical exercise-related risks such as muscle soreness or strain. The specific side effects will depend on individual health conditions.

Eligibility Criteria

Inclusion Criteria

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

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I have had a bone break, not including skull, hands, or feet, in the last 2 years.

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I am a man over 60 at high risk for breaking bones and live in my own home.

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I have had a hip or spine fracture or multiple weak-bone fractures after age 40.

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I am taking medication approved by Health Canada to lower my risk of bone fractures.

Exclusion Criteria

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

Select...

I haven't had worsening heart failure or COPD issues recently.

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I cannot communicate in English or French.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 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

Adherence to the exercise and nutrition interventions (feasibility objective)

Perceived usability and satisfaction of the telehealth platform application (feasibility objective)

Study recruitment rates (feasibility objective)

+1 more

Secondary study objectives

Change in balance

Change in dynamic balance

Change in fear of falling in community-dwelling older adults

+13 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

Group I: Misterfit online groupExperimental Treatment1 Intervention

The Misterfit online group will receive a 12-month virtually-delivered fracture prevention intervention that includes a personalized gender-tailored strength training and balance-based exercise program, nutritional counselling and fall and fracture prevention education.

Group II: MisterFit offline groupExperimental Treatment1 Intervention

The Misterfit offline group will act as an attention control group receiving a fracture prevention intervention with the same components as the experimental group, but the components will not be virtual, personalized or gender-tailored.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Attention Control

2014

Completed Phase 2

~6520

0 / 6Eligibility 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

Common treatments for osteoporosis include pharmacologic agents like bisphosphonates, which inhibit bone resorption by osteoclasts, thereby increasing bone mineral density and reducing fracture risk. Non-pharmacologic interventions such as strength training and balance exercises improve muscle strength, coordination, and functional mobility, which are essential for preventing falls. Nutritional counseling ensures adequate intake of calcium and vitamin D, vital for bone health. Combining these treatments addresses both bone integrity and functional mobility, offering a comprehensive approach to managing osteoporosis.

Effect of twelve-month physical exercise program on patients with osteoporotic vertebral fractures: a randomized, controlled trial.