NCT05927623: MisterFIt

Multifaceted Intervention Using Telehealth to Reduce the Risk of Falls and Fractures in Older Men

Active, enrolled NA Last updated 20 July 2025

What this trial tests

NA trial testing Multifaceted Virtual Fracture Prevention Program in Osteoporosis in 60 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

7 February 2023

Primary endpoint
31 March 2026

31 March 2026

Quick facts

Lead sponsor	McGill University Health Centre/Research Institute of the McGill University Health Centre
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	7 February 2023
Primary completion	31 March 2026
Estimated completion	31 March 2026
Sites	5 locations across Canada

Drugs / interventions tested

• Multifaceted Virtual Fracture Prevention Program
• Attention Control

Conditions studied

• Osteoporosis — all drugs for Osteoporosis →
• Osteoporotic Fractures — all drugs for Osteoporotic Fractures →
• Osteoporosis, Age-Related — all drugs for Osteoporosis, Age-Related →
• Muscle Loss — all drugs for Muscle Loss →

Sponsor

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

Who can join

60 and older, male only, with Osteoporosis or Osteoporotic Fractures. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Men sustain over one-third of osteoporosis-related fractures worldwide. The burden of osteoporotic fractures in older men is substantial, and men suffer significantly worse fracture-related outcomes than women. Following a fracture, men sustain greater rates of subsequent fractures, loss of autonomy, and mortality than women and the imminent risk of re-fracture is several times higher in men than in women. Functional mobility, known to predict falls and fractures, is also notably worse in men following a fracture. In the fiscal year 2007-08, the overall annual costs of osteoporosis in Canadian men was evaluated to be $910 million.

Osteoporosis is primarily considered a disease of older women, and men are remarkably under-evaluated and under-treated for it. Recognition of sex and gender influences on skeletal health in men has been very slow; akin to the gap in cardiovascular diseases, where women are far less likely to receive guideline-recommended investigations and treatment.

Over 85% of Canadian men who suffer from fragility fractures do not receive osteoporosis screening and/or treatment strategies. The existence of this care gap in men underscores our current struggle to overcome important barriers including: 1) men's lack of awareness of the critical impact of osteoporosis and fractures on several aspects of their lives, and of the benefits of treatment; and 2) the absence of comprehensive and accessible treatments tailored to men.

Informed by the Knowledge-to-Action framework, we aim to address these barriers by adapting interventions with proven efficacy to engage men at high fracture risk in health behaviour change.

The current protocol is for a pilot RCT to determine the feasibility of recruitment and retention, adherence to, and acceptability of the virtually-delivered fracture prevention intervention only.

Our long-term goal is to conduct a large pragmatic randomized controlled trial (RCT) to address the research question: In older adults at high risk for fractures who self-identify as men, does anti-osteoporosis pharmacotherapy in conjunction with a virtually-delivered intervention that includes a gender-tailored strength training and balance based exercise program and nutritional counselling, improve functional mobility compared to anti-osteoporosis pharmacotherapy in conjunction with an attention control intervention.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.