Telehealth Intervention for Osteoporosis in Older Men

(MisterFIt Trial)

Not currently recruiting at 4 trial locations

Overseen By Study Coordinator

Age: 18+

Sex: Male

Trial Phase: Academic

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 All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a virtual program designed to help older men at high risk for fractures improve functional mobility. It combines strength training, balance exercises, and nutritional counseling with existing anti-osteoporosis medications. The goal is to determine if this program, called the Multifaceted Virtual Fracture Prevention Program, is more effective than standard treatments. Men aged 60 or older, who have experienced significant fractures or are on specific osteoporosis medications, might be suitable candidates for the trial. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future fracture prevention strategies.

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 prior data suggests that this protocol is safe for older men?

Research has shown that telehealth programs for osteoporosis, like the one under study, are generally safe for older adults. Previous studies found that these online programs, which often include advice on exercise and nutrition, are usually well-received by participants and have not resulted in any major unwanted side effects.

For the exercise and nutrition components, studies indicate that these activities are generally safe for most people. They can improve strength and balance, potentially lowering the risk of falls and broken bones.

Overall, the telehealth approach appears promising for safety, as it allows for close monitoring and support without requiring frequent in-person visits. This convenience helps ensure participants use the programs correctly and receive help if needed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way of managing osteoporosis in older men using telehealth. Unlike traditional treatments that often involve in-person visits for medication prescriptions like bisphosphonates or hormone replacement therapies, this approach includes a multifaceted virtual program. It offers personalized, gender-tailored exercise routines, nutritional counseling, and education on preventing falls and fractures, all delivered online. This method could make osteoporosis management more accessible and convenient, potentially improving patient outcomes by making it easier for patients to stick to their treatment plans.

What evidence suggests that this trial's treatments could be effective for osteoporosis in older men?

Research has shown that telehealth, or online healthcare, can help manage osteoporosis, especially in older adults. A review found that virtual programs for osteoporosis can improve physical abilities like strength and balance, which are crucial for preventing falls and broken bones. In this trial, participants in the Misterfit online group will receive a 12-month virtually-delivered fracture prevention intervention. This includes a personalized, gender-tailored strength training and balance-based exercise program, nutritional counseling, and fall and fracture prevention education. An earlier study discovered that programs aimed at preventing fractures, like the one under testing, can reduce the risk of additional fractures. This online approach also includes exercises to build strength and advice on healthy eating, both of which support strong bones. Early results suggest that these online tools make it easier for people to follow their treatment plans, potentially leading to better health outcomes for older men at risk. ^{1 2 3 5 6}

Who Is on the Research Team?

Suzanne Morin, MD

Principal Investigator

Research Institute of the McGill University Health Centre

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Attention Control
• Multifaceted Virtual Fracture Prevention Program

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.

How Is the Trial Designed?

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+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05927623

Study Details | NCT05927623 | Multifaceted Intervention ... Exploratory outcomes will include the number of falls and fractures, changes in physical function (measured by lower extremity strength, gait speed, and balance) ...

2. withpower.com withpower.com/trial/phase-osteoporosis-age-related-1-2023-6b1bc

Telehealth Intervention for Osteoporosis in Older Men · Info ... This trial aims to help older men at high risk of fractures by combining osteoporosis medication with online exercise and nutrition sessions.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9438367/

Remote Management of Osteoporosis - PMC - PubMed Central This review explores the advantages and disadvantages of telehealth use for osteoporosis management while highlighting recent studies of clinical importance.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11211169/

Effectiveness of fracture liaison service in reducing the risk ... This review found clinically important moderate certainty evidence showing that the risk of secondary fragility fracture was lower in the FLS intervention at ≥ ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04947722

Study Details | NCT04947722 | The PREVENT Trial: a ... The study will examine if this program is effective for decreasing hip fractures by assigning some homes to receive the PREVENT program (intervention group) and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11281980/

Secondary fracture prevention in primary care - PubMed Central This literature review examines the barriers to secondary fracture prevention in primary care and evaluates the effectiveness of targeted primary care ...