Telehealth Intervention for Osteoporosis in Older Men

(MisterFIt Trial)

Recruiting at4 trial locations

Overseen by Suzanne Morin, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Must be taking: Anti-osteoporosis medications

Disqualifiers: Severe cognitive impairment, Terminal illness, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants can be on certain osteoporosis medications, so you might be able to continue those.

What data supports the effectiveness of the treatment Attention Control, Attentional Control, Executive Attention, Endogenous Attention, Multifaceted Virtual Fracture Prevention Program for osteoporosis in older men?

Research shows that telehealth interventions, like using telecarers, can improve treatment and compliance rates in osteoporosis care for elderly patients. Additionally, direct-to-patient educational interventions have been shown to increase the use of certain osteoporosis medications and improve readiness for behavior change in some groups. ^{1 2 3 4 5}

How does the telehealth intervention for osteoporosis in older men differ from other treatments?

The telehealth intervention for osteoporosis in older men is unique because it uses remote communication technology to monitor and improve treatment compliance, which is different from traditional in-person care. This approach can help address the treatment gap by providing ongoing support and monitoring, potentially increasing medication use and adherence. ^{1 2 3 6 7}

Research Team

Suzanne Morin, MD

Principal Investigator

Research Institute of the McGill University Health Centre

Eligibility Criteria

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.

Inclusion Criteria

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

I have low bone density and either a severe spine fracture, certain health conditions, or have fallen twice last year.

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

Exclusion Criteria

I have had a spine fracture in the last 4 months or a limb fracture in the last 2 months.

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

No access to a mobile device, tablet, or computer with a camera

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-month virtually-delivered fracture prevention intervention including a personalized gender-tailored strength training and balance-based exercise program, nutritional counselling, and fall and fracture prevention education

12 months

Monthly virtual visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Attention Control (Behavioural Intervention)
• Multifaceted Virtual Fracture Prevention Program (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: Misterfit online group Experimental Treatment 1 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 group Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

476

Recruited

170,000+

Dr. Lucie Opatrny

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

President and Executive Director since 2023

MDCM and Master's in Epidemiology and Biostatistics from McGill University, Master's in Healthcare Management and Diploma in Advanced Negotiation from Harvard University

Dr. Patrizia Cavazzoni

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

Chief Medical Officer

MD from McGill University, residency in Psychiatry and fellowship in Mood Disorders at the University of Ottawa

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Executive Officer

MD, University of Ottawa

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Medical Officer

MD, University of Ottawa

Findings from Research

A 12-year follow-up of a randomized controlled trial involving 347 women showed that while osteoporosis knowledge remained higher than baseline, the educational interventions (Osteoporosis Prevention and Self-Management Course and feedback on fracture risk) did not sustain their initial benefits on knowledge or improve self-efficacy over time.

Women from households with unemployed main financial providers experienced a decrease in osteoporosis knowledge, suggesting socioeconomic factors may influence long-term retention of health information, highlighting the need for more frequent education and alternative strategies to enhance self-efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of individualized bone density feedback and educational interventions on osteoporosis knowledge and self-efficacy: a 12-yr prospective study. Wu, F., Laslett, LL., Wills, K., et al.[2016]

In a study involving 537 hip fracture patients, the use of telecarers to monitor osteoporosis treatment led to a 73.6% treatment initiation rate after 12 months, highlighting the potential effectiveness of this approach in elderly patients.

The main barriers to treatment initiation included patient or family rejection (34.4%) and physician failure to prescribe (24.4%), indicating that both patient engagement and physician awareness are critical for improving osteoporosis management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telecarers improve osteoporosis treatment and compliance rates in secondary osteoporosis prevention for elderly hip fracture patients. Gani, LU., Tan, FCL., King, TFJ.[2023]

A randomized clinical trial involving 2684 women with a history of fractures found that a tailored video intervention did not significantly increase overall osteoporosis medication use compared to usual care, with both groups showing similar low rates of medication adherence (around 11.7% for the intervention group).

However, the intervention did lead to increased use of nonbisphosphonate medications and bone mineral density (BMD) testing in certain subgroups, indicating that while broad patient activation strategies may be challenging, they can still positively influence specific aspects of osteoporosis care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Multimodal, Direct-to-Patient Educational Intervention Targeting Barriers to Osteoporosis Care: A Randomized Clinical Trial. Danila, MI., Outman, RC., Rahn, EJ., et al.[2019]

Compliance with oral bisphosphonates for osteoporosis is low, primarily due to patients' deliberate choices rather than forgetfulness, leading to increased healthcare costs and reduced effectiveness in preventing fractures.

Understanding the reasons behind poor adherence, including gender differences and healthcare management styles, is crucial for developing effective interventions, with preliminary evidence suggesting that psychobehavioral strategies may enhance patient motivation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral bisphosphonate compliance and persistence: a matter of choice? Silverman, SL., Schousboe, JT., Gold, DT.[2021]

In a study of 2,678 mid-aged Canadians, only 25% of men and 33% of women accurately recalled their osteoporosis diagnoses after receiving feedback on their bone mineral density (BMD) results, indicating a significant gap in awareness.

While direct feedback to participants did not enhance recall of osteoporosis diagnoses, it did improve awareness of borderline or normal BMD results, suggesting that how results are communicated can influence understanding of bone health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct-to-participant feedback and awareness of bone mineral density testing results in a population-based sample of mid-aged Canadians. Kingwell, E., Prior, JC., Ratner, PA., et al.[2021]

A study involving 400 women under 50 years old found that self-regulation is the strongest predictor of calcium intake, which is crucial for preventing osteoporosis, explaining 73% of the variance in intake levels.

The average calcium intake among participants was 909.94 mg/day, indicating that understanding social-cognitive factors can help develop effective osteoporosis prevention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The social-cognitive determinants of calcium intake for preventing osteoporosis in women in Isfahan: A cross-sectional study using path analysis. Nematollahi, M., Eslami, AA.[2022]

A telephone-based osteoporosis clinic significantly increased medication use among women aged 60 and older, with 68.8% of participants using osteoporosis medication after one year compared to only 45.1% in the usual care group.

The study involved 235 women, and the intervention's effectiveness was highlighted by a statistically significant difference in medication adherence (P < .001), suggesting that regular follow-up can enhance treatment uptake for osteoporosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A telephone-based intervention for increasing the use of osteoporosis medication: a randomized controlled trial. Waalen, J., Bruning, AL., Peters, MJ., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of individualized bone density feedback and educational interventions on osteoporosis knowledge and self-efficacy: a 12-yr prospective study. [2016]

2. India pubmed.ncbi.nlm.nih.gov

Telecarers improve osteoporosis treatment and compliance rates in secondary osteoporosis prevention for elderly hip fracture patients. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Multimodal, Direct-to-Patient Educational Intervention Targeting Barriers to Osteoporosis Care: A Randomized Clinical Trial. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Oral bisphosphonate compliance and persistence: a matter of choice? [2021]

5. England pubmed.ncbi.nlm.nih.gov

Direct-to-participant feedback and awareness of bone mineral density testing results in a population-based sample of mid-aged Canadians. [2021]

6. India pubmed.ncbi.nlm.nih.gov

The social-cognitive determinants of calcium intake for preventing osteoporosis in women in Isfahan: A cross-sectional study using path analysis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A telephone-based intervention for increasing the use of osteoporosis medication: a randomized controlled trial. [2022]