Using telehealth to prevent falls and fractures in older men
Multifaceted Intervention Using Telehealth to Reduce the Risk of Falls and Fractures in Older Men (MisterFit): A Pilot Study
This study is testing a virtual program to help older men at high risk of fractures stay active and eat better to see if it can prevent falls and broken bones.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 60 Years and up |
| Sex | Male |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Drugs / interventions | denosumab, romozosumab |
| Locations | 5 sites (Calgary, Alberta and 4 other locations) |
| Trial ID | NCT05927623 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the feasibility of a multifaceted virtual fracture prevention program for older men at high risk of osteoporosis-related fractures. It will assess recruitment and retention rates, as well as adherence to exercise and nutrition interventions over a 12-month period. Participants will be community-dwelling men aged 60 and above who meet specific criteria indicating a high risk for fractures. The study will involve multiple centers and will help inform future larger randomized controlled trials.
Who should consider this trial
Good fit: Ideal candidates are community-dwelling men aged 60 and older with a high risk of fractures due to osteoporosis.
Not a fit: Patients who are not men or those under 60 years of age may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the risk of falls and fractures in older men, improving their overall health and quality of life.
How similar studies have performed: Other studies have shown success with similar multifaceted interventions for fall prevention, indicating potential for positive outcomes in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
Community-dwelling individuals ≥ 60 years who self-identify as men will be considered eligible if their risk for fracture is evaluated to be high, defined by the presence of one of the following inclusion criteria: * Individuals on a Heath Canada-approved anti-osteoporosis medication (oral or intravenous bisphosphonate, denosumab, teriparatide, or romozosumab) to reduce fracture risk * Prior hip or clinically diagnosed vertebral fracture or prior multiple fragility fractures since age 40 * Fracture at any skeletal site (excluding skull, hands, and feet) within the previous 2 years * Ten-year probability of major osteoporotic fracture of ≥20% using the FRAX tool * BMD T-score of ≤ -2.0 (performed as part of usual clinical care) WITH either the presence of one or more moderate or severe vertebral fractures on spine radiography OR the presence of ≥1 comorbidities (Diabetes Type I or Type II if on treatment, Parkinson's disease, congestive heart failure, chronic obstructive pulmonary disease (COPD) with previous systemic corticosteroid exposure, prostate cancer with current or prior recent (≤ 2 years) use of hormonal therapy) OR ≥ 2 falls in the previous year * BMD T-score of ≤ -2.5 and ≥ 70 years of age Exclusion Criteria: * Inability to communicate in English or French; * No access to a mobile device, tablet, or computer with a camera; * Clinical or symptomatic spine fracture in the last 4 months, or a lower/upper limb fracture in the last 2 months; * 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 * Currently doing or planning to start doing either: A) Resistance training exercises with a self-rated intensity of very hard (e.g., rated ≥ 8 on a scale from 0-10) for two or more times a week OR B) Exercises to improve balance for two or more times a week * Unable to perform basic activities of daily living or severe cognitive impairment or terminal illness * Presence of absolute exercise contraindications unless physician approval is obtained if contraindications are present
Where this trial is running
Calgary, Alberta and 4 other locations
- University of Calgary — Calgary, Alberta, Canada (Recruiting)
- McMaster University — Hamilton, Ontario, Canada (Recruiting)
- University Health Network — Toronto, Ontario, Canada (Recruiting)
- McGill University Health Centre — Montreal, Quebec, Canada (Recruiting)
- Centre Hospitalier Universitaire de Québec — Québec, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Suzanne Morin, MD — Research Institute of the McGill University Health Centre
- Study coordinator: Study Coordinator
- Email: michelle.wall@mail.mcgill.ca
- Phone: (514) 934-1934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.