OsteoporosisFORTIFYNCT07611097
Osteoporosis and Sarcopenia Prevention in Middle-Aged Population
A study testing Intervention Group in people with Osteoporosis and Sarcopenia, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This initiative is designed to yield substantial and multi-level benefits for the Hong Kong community by pioneering a transformative model of preventive healthcare. It represents the largest randomized controlled trial for osteoporosis and sarcopenia prevention in the region, adopting a comprehensive approach to… Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Sarcopenia
- What is being tested?
- Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,336 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2026to 31 May 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- General Population: Women and men aged 40-60 years, defined as age groups where the rate of injuries were still relatively lower, thus considered as a low to moderate risk cohort for osteoporosis.
- Risk profile: Targets a low to moderate risk cohort for osteoporosis (e.g., as defined by no prior fragility fracture and questionnaire). This aligns with the study's primary prevention objective.
- Individuals with well-controlled comorbidities like hypertension, diabetes, or pre-diabetes can be included in the study program. Exercise and healthy nutritional diets can also help treat their existing health conditions.
Who cannot join
- Significant comorbidities: Individuals with existing (e.g., severe or uncontrolled) medical illness, due to risk to aerobic exercise. This includes, but is not limited to, active ischemic heart disease, unstable angina, uncontrolled hypertension, or other conditions as determined by study physicians.
- High baseline activity: Individuals who have engaged in >4 hours intensive sports per week will be excluded. This population is deemed to be at very low risk, thus would likely derive minimal additional benefit from the intervention, and their inclusion could represent inefficient use of finite resources (e.g., DEXA scanning services).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
Queen Mary Hospital, The University of Hong Kong, Hong Kong,
Hong Kong
Christian FANG, +852 22554581, cfang@hku.hk
Christian FANG
About this study
This initiative is designed to yield substantial and multi-level benefits for the Hong Kong community by pioneering a transformative model of preventive healthcare. It represents the largest randomized controlled trial for osteoporosis and sarcopenia prevention in the region, adopting a comprehensive approach to fracture prevention through innovative fitness, lifestyle, and digital strategies.
The study's primary objective is to evaluate the efficacy of preventing fractures, osteoporosis, and sarcopenia through an incentivized program of fitness and lifestyle modifications in adults aged 40-60. The secondary objectives include: (1) to validate the use of simple, low-cost measures (grip strength and InBody body composition analysis) as reliable proxy indicators for osteoporosis and sarcopenia risk relative to the gold-standard DEXA scan; (2) to develop a formal, standardized clinical protocol for early detection and prevention, including specified DEXA anatomical measurement sites, for use by healthcare professionals in primary and community care settings; (3) to assess changes in exercise behavior, musculoskeletal health, physical function, health literacy, and participant engagement with the digital (AI chatbot) support system; (4) to analyze the cost-effectiveness of the intervention compared to standard care or pharmacological treatment, including an assessment of healthcare utilization and Quality-Adjusted Life Years (QALYs).
Read more
After baseline screening and consent, participants are randomly assigned to one of two groups (1:1 ratio) with intention-to-treat principles. The Control Group will receive passive, static support. This involves participating in one initial FUN Day, receiving standard exercise videos, using a passive chatbot for data reporting, undergoing start and end DEXA scans (which require a co-payment), completing a 3-month assessment, and receiving souvenirs at the study start and end. Meanwhile, the Intervention Group will receive active, dynamic support designed to build and reinforce healthy habits. This involves participating in the initial FUN Day, a reinforcement FUN Day at 2 months, nine mandatory structured exercise touchpoints, using an active chatbot with reminders, feedback, and gamification, undergoing start and end DEXA scans (which require a co-payment), completing a 3-month assessment, and receiving ongoing incentives and souvenirs at multiple points. Therefore, researchers will compare between the control and intervention groups to see if intervention can prevent osteoporosis and sarcopenia at a population level.
All participants will undergo a series of assessments at specific timepoints. This includes two DEXA scans (at the study start and in the fourth year, requiring a participant co-payment), InBody composition analysis, and physical health assessments (e.g., grip strength, balance, cardiovascular fitness). These assessments will be performed at baseline (during the first FUN Day), 3 months, 12 months, 24 months, and 36 months. A long-term follow-up will continue for up to 10 years to monitor adverse health events such as falls and fractures. Participants will also complete questionnaires via an AI chatbot at baseline, 3 months, and annually during follow-up. The collected data will encompass health literacy (e.g., osteoporosis/sarcopenia knowledge scores), digital engagement (e.g., chatbot responsiveness), and economic outcomes (e.g., incremental cost per Quality-Adjusted Life Year [QALY] gained). Data analysis will employ appropriate statistical methods to compare outcomes between the control and intervention groups across all assessments and timepoints.
Read the detailed description
The proposed FORTIFY project is a prospective, multi-centre, randomized, controlled trial designed with patient-centred objectives. This pilot project aims to significantly prevent fracture and reduce the prevalence of osteoporosis within the study cohort, thereby shifting the participants at-risk age to a lower risk category over a multi-year follow-up period. Targeted participants are adults aged 40-60 years old identified as being low-to-moderate risk for osteoporosis. After baseline screening and consent, the participants will be randomly assigned to one of two groups for a 12-month intervention period, with subsequent three years follow-up. In brief, the control group will receive passive and static support, while intervention group will receive more active, dynamic, and sustained support designed to build and reinforce healthy habits. All participants will undergo dual-energy X-ray absorptiometry (DEXA) scanning, in-body measurements, and health assessments (e.g., grip strength, endurance, balance, cardiovascular fitness, etc.) at the start and end of the project. All participants will also be continuously assessed during the three years follow-up and long-term follow-up beyond the study period including any fall and fracture event.
- Conditions
- Osteoporosis, Sarcopenia
- Being tested
- Intervention Group, Control Group
- Keywords
- Randomized Controlled Trial, Middle-Aged Population, Osteoporosis Prevention, Sarcopenia Prevention, AI Chatbot, DEXA Alternative
- Medical subject headings
- Osteoporosis, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupBehavioural
The interventions include FUN Day, reinforcement FUN Day (2 months), nine mandatory structured exercise touchpoints, active chatbot with reminders/feedback/gamification, start and end DEXA scans (co-payment), 3-month assessment, ongoing incentives, and souvenirs at multiple points.
Control GroupBehavioural
The control group serves to establish baseline comparison with the intervention group to determine whether this new and intensive program is significantly better than the current standard of advice and basic tools. These include FUN Day, exercise videos, passive chatbot for data reporting, start and end DEXA scans (co-payment), 3-month assessment, and souvenirs at study start and end.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group will receive active, dynamic, and sustained support designed to build habits and maintain long-term healthy habits. Receives: Behavioral: Intervention Group |
| Control Group | Active comparator | The control group will receive passive and static support. Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture risk
It measures the incidence of fracture or adverse events, which is the ultimate clinical endpoint for osteoporosis prevention.
Unit of measure: Count of fractures (per participant) Source: Electronic report/questionnaire and medical records for verification
Measured: To be reported monthly throughout study period (years 0-3) and annually after the study ends with long-term follow up (years 4-10).
Secondary outcomes (17)
Quality-Adjusted Life Years ("QALYs")
It assesses cost-effectiveness compared to pharmacological treatment, using the EQ-5D-5L questionnaire to calculate Quality-Adjusted Life Years (QALYs), which measure both the quality and length of life. This calculation also incorporates cost data derived from both the program itself and overall healthcare utilization.
Unit of measure: 0.0 to 1.0 (the higher the better), though the scale can technically go below zero. A score of 1.0 represents perfect, full, or optimal health, while a score of 0.0 is equivalent to a health state of death. Scores between 0.01 and 0.99 reflect living with varying degrees of disability.
Source: participant self-administered questionnaire
Measured: Questionnaire to be taken at baseline (first FUN Day), post-intervention assessment day at 3-month, and annually during the study period (years 1-3). Long-term follow up if possible (annually after study ends, years 4-10).
Health literacy
Knowledge of osteoporosis, sarcopenia, exercise, and healthy diet tested. Unit of measure: total source (higher = better understanding) reflects the participants' capacity to manage their own risk and to reject harmful misconception.
Unit of Measure: Summary score, higher indicates better knowledge (exact range to be specified).
Source: Short, self-administered electronic questionnaire.
Measured: Questionnaire to be taken at baseline (during first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after study ends, years 4-10).
Change in bone mineral density (BMD)
Participants' BMD measurements done by DEXA scans (e.g., Z-score or T-score at lumbar spine and hip). It is a gold-standard indicator of osteoporosis risk and primary prevention target.
Unit of measure: T-score or Z-score (unitless). T-score compares to healthy young adult (normal ≥ -1.0; osteopenia -2.5 to -1.0; osteoporosis ≤ -2.5). Z-score compares to age-matched population (normal > -2.0; below expected ≤ -2.0).
Source: DEXA scan
Measured: Scans to be done twice, once at baseline (after first FUN Day) and another scan between years 2-3 of the study.
Fall risk
Measures the participants' use of specialist and inpatient services (e.g., Accident \& Emergency Department visits).
Unit of Measure: Count of such events during the observation period. Source: Electronic questionnaire/report and medical record verification
Measured: To be reported monthly throughout study period (years 0-3) and annually after the study ends with long-term follow up (years 4-10).
Upper body musculoskeletal strength
Assessed based on grip strength value using digital dynamometer. The participant squeezes the device with maximum effort and force is recorded. It is a strong predictor of overall muscle strength and fracture risk. It is low cost and scalable.
Unit of measure: Force in kilogram (kg). ≥24 kg target, which aligns with Asian fracture risk thresholds Source: Physical assessment with dynamometer
Measured: Assessment to be taken at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Intervention group has additional measurements during reinforcement FUN Day before the 3-month assessment day.
Lower body musculoskeletal strength
Assessed by using the 30-second chair stand test and it reflects functional mobility, including fall risk, endurance, and daily function. Participants are asked to stand up fully and sit down again as many times as possible in 30 seconds.
Unit of Measure: Number of completed stands. Higher counts indicate better lower-body strength and functional mobility Source: Physical assessment
Measured: Assessment to be taken at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Intervention group has additional measurements during reinforcement FUN Day before the 3-month assessment day.
Balance
Assessed using the single leg stance test. The participant stands on one leg at a time with eyes open and arms positioned at the sides. The time they can maintain the position without the raised foot touching the ground is recorded, with a maximum of 30 seconds per trial. Each leg is tested separately. Longer standing times indicate better balance, which reflects functional mobility, fall risk, endurance, and daily function.
Unit of Measure: The time in seconds from when the raised foot leaves the floor until it touches the ground, recorded as a value less than 30 seconds. If the participant maintains the position for 30 seconds or longer, the score is recorded as ">30 seconds" (maximum).
Source: Physical assessment.
Measured: Assessment to be taken at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Intervention group has additional measurements during reinforcement FUN Day before the 3-month assessment day.
Cardiovascular fitness
Assessed by using the three-minute step test and it reflects functional mobility, including fall risk, endurance, and daily function.
Unit of Measure: Heart rate measured for 60 seconds or 1 minute in beats per minute (bpm) Source: Physical Assessment with the heart rate monitor
Measured: Assessment to be taken at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Intervention group has additional measurements during reinforcement FUN Day before the 3-month assessment day.
Lean muscle mass distribution
Assessed by using the InBody composition analysis. It serves as a proxy for sarcopenia risk and early marker of physical decline.
Unit of Measure: Estimated lean mass in kilograms (kg) Source: InBody machine
Measured: Assessment to be taken at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Intervention group has additional measurements during reinforcement FUN Day before the 3-month assessment day.
Exercise adherence
Measured by using the Exercise Adherence Rating Scale (EARS) is a self-administered questionnaire delivered by the chatbot. It contains 6 items (e.g., "I do my exercise as prescribed") rated on a 5-point Likert scale (0 = never, 4 = always).
Unit of Measure: Total scores range from 0 to 24, with higher scores indicating better adherence.
Source: Electronic self-reported questionnaire.
Measured: To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
Exercise frequency
Measured as the number of exercise sessions logged by the participant via chatbot.
Unit of measure: Number of sessions. Source: Electronic questionnaire and records
Measured: To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
Physical activity level
Measured using the Physical Activity Rating Scale-3 (PARS-3). This self-report questionnaire assesses the frequency, duration, and intensity of physical activity. Each criterion is scored on a 5-point scale.
Unit of Measure: Responses are converted into a continuous score. Generally to find the total score, the scores from three different categories are multiplied together, resulting in a final score between 0 and 100. Higher scores represent higher overall physical activity levels beyond the structured program sessions. This total categorizes a person's physical activity into low (lower or equivalent to 19 points), moderate (20 to 42 points), or high (higher or equivalent to 43 points) levels. Exact range to be specified) Source: Electronic self-reported questionnaire
Measured: To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
Dietary habits (e.g. calcium and vitamin D)
Measured based on self-reported nutrition survey. It is essential for bone formation and muscle health.
Unit of measure: Score, with higher score showing better adherence to dietary guidelines (exact range to be specified) Source: Chatbot questionnaire
Measured: To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
Self-efficacy for exercise
Measured based on self-reported questionnaire using Self-Efficacy for Exercise Scale - Chinese (SEE-C). It predicts long-term maintenance of physical activity together with the PRETIE-Q questionnaire.
Unit of Measure: Total score (exact range to be determined), with higher score indicates greater self-efficacy.
Source: Electronic questionnaire.
Measured: To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
Exercise tolerance
Measured by using PRETIE-Q questionnaire to measure preference for and tolerance of high-intensity exercise. It predicts long-term maintenance of physical activity together with the Self-Efficacy for Exercise Scale - Chinese (SEE-C) questionnaire.
Unit of Measure: Score (exact range to be specified), with higher score means greater preference or tolerance.
Source: Electronic self-reported questionnaire
Measured: To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
Chatbot engagement
Measured based on chatbot usage data captured (with backend digital analytics) throughout the 4-year study. It is a proxy for sustained participant engagement.
Unit of measure: number of interactions (count) or response rate (%), to be determined later. Continuous with range determined later and higher engagement means better outcome measure.
Source: Digital usage data with backend digital analytics.
Measured: To be reported monthly throughout the 4-year study (years 0-4). Long-term follow up if possible.
Satisfaction on the program
Measured based on short, self-administered questionnaire by chatbot.
Measured: To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 May 2030 (estimated)
- Study completion31 May 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study adopts a two-arm, parallel RCT with 1:1 randomization of participants aged 40-60 years. Simple randomization will be used to allocate participants to either intervention or control group. The control group will receive passive and static support, while the intervention group will receive active, dynamic, and sustained support designed to build habits and maintain long-term healthy habits.
- Masking
- None (open label)
- Enrolment
- 8,336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Jockey Club Charities Trust, The Family Planning Association of Hong Kong
- Responsible party
- Principal investigator, Prof. Christian Xinshuo Fang, The University of Hong Kong
- Investigators
- Christian FANG, Principal investigator, Dept of Orthopaedics and Traumatology, Queen Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611097
- Sponsor's protocol ID
- UW 26
- Other IDs
- 2026-0026-002
- Acronym
- FORTIFY
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized dataset to be included as supplementary data in final publication
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoporosis and Sarcopenia Prevention in Middle-Aged Population
- ClinicalTrials.gov ID
- NCT07611097
- Acronym / sponsor ID
- FORTIFY / UW 26
- Conditions
- Osteoporosis, Sarcopenia
- Keywords
- Randomized Controlled Trial, Middle-Aged Population, Osteoporosis Prevention, Sarcopenia Prevention, AI Chatbot, DEXA Alternative
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8,336 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The Hong Kong Jockey Club Charities Trust, The Family Planning Association of Hong Kong
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 May 2036 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This initiative is designed to yield substantial and multi-level benefits for the Hong Kong community by pioneering a transformative model of preventive healthcare. It represents the largest randomized controlled trial for osteoporosis and sarcopenia prevention in the region, adopting a comprehensive approach to fracture prevention through innovative fitness, lifestyle, and digital strategies.
The study's primary objective is to evaluate the efficacy of preventing fractures, osteoporosis, and sarcopenia through an incentivized program of fitness and lifestyle modifications in adults aged 40-60. The secondary objectives include: (1) to validate the use of simple, low-cost measures (grip strength and InBody body composition analysis) as reliable proxy indicators for osteoporosis and sarcopenia risk relative to the gold-standard DEXA scan; (2) to develop a formal, standardized clinical protocol for early detection and prevention, including specified DEXA anatomical measurement sites, for use by healthcare professionals in primary and community care settings; (3) to assess changes in exercise behavior, musculoskeletal health, physical function, health literacy, and participant engagement with the digital (AI chatbot) support system; (4) to analyze the cost-effectiveness of the intervention compared to standard care or pharmacological treatment, including an assessment of healthcare utilization and Quality-Adjusted Life Years (QALYs).
After baseline screening and consent, participants are randomly assigned to one of two groups (1:1 ratio) with intention-to-treat principles. The Control Group will receive passive, static support. This involves participating in one initial FUN Day, receiving standard exercise videos, using a passive chatbot for data reporting, undergoing start and end DEXA scans (which require a co-payment), completing a 3-month assessment, and receiving souvenirs at the study start and end. Meanwhile, the Intervention Group will receive active, dynamic support designed to build and reinforce healthy habits. This involves participating in the initial FUN Day, a reinforcement FUN Day at 2 months, nine mandatory structured exercise touchpoints, using an active chatbot with reminders, feedback, and gamification, undergoing start and end DEXA scans (which require a co-payment), completing a 3-month assessment, and receiving ongoing incentives and souvenirs at multiple points. Therefore, researchers will compare between the control and intervention groups to see if intervention can prevent osteoporosis and sarcopenia at a population level.
All participants will undergo a series of assessments at specific timepoints. This includes two DEXA scans (at the study start and in the fourth year, requiring a participant co-payment), InBody composition analysis, and physical health assessments (e.g., grip strength, balance, cardiovascular fitness). These assessments will be performed at baseline (during the first FUN Day), 3 months, 12 months, 24 months, and 36 months. A long-term follow-up will continue for up to 10 years to monitor adverse health events such as falls and fractures. Participants will also complete questionnaires via an AI chatbot at baseline, 3 months, and annually during follow-up. The collected data will encompass health literacy (e.g., osteoporosis/sarcopenia knowledge scores), digital engagement (e.g., chatbot responsiveness), and economic outcomes (e.g., incremental cost per Quality-Adjusted Life Year [QALY] gained). Data analysis will employ appropriate statistical methods to compare outcomes between the control and intervention groups across all assessments and timepoints.
Detailed description
The proposed FORTIFY project is a prospective, multi-centre, randomized, controlled trial designed with patient-centred objectives. This pilot project aims to significantly prevent fracture and reduce the prevalence of osteoporosis within the study cohort, thereby shifting the participants at-risk age to a lower risk category over a multi-year follow-up period. Targeted participants are adults aged 40-60 years old identified as being low-to-moderate risk for osteoporosis. After baseline screening and consent, the participants will be randomly assigned to one of two groups for a 12-month intervention period, with subsequent three years follow-up. In brief, the control group will receive passive and static support, while intervention group will receive more active, dynamic, and sustained support designed to build and reinforce healthy habits. All participants will undergo dual-energy X-ray absorptiometry (DEXA) scanning, in-body measurements, and health assessments (e.g., grip strength, endurance, balance, cardiovascular fitness, etc.) at the start and end of the project. All participants will also be continuously assessed during the three years follow-up and long-term follow-up beyond the study period including any fall and fracture event.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study adopts a two-arm, parallel RCT with 1:1 randomization of participants aged 40-60 years. Simple randomization will be used to allocate participants to either intervention or control group. The control group will receive passive and static support, while the intervention group will receive active, dynamic, and sustained support designed to build habits and maintain long-term healthy habits.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Intervention GroupThe intervention group will receive active, dynamic, and sustained support designed to build habits and maintain long-term healthy habits. |
| Control Group | Active comparator | Behavioral: Control GroupThe control group will receive passive and static support. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- General Population: Women and men aged 40-60 years, defined as age groups where the rate of injuries were still relatively lower, thus considered as a low to moderate risk cohort for osteoporosis.
- Risk profile: Targets a low to moderate risk cohort for osteoporosis (e.g., as defined by no prior fragility fracture and questionnaire). This aligns with the study's primary prevention objective.
- Individuals with well-controlled comorbidities like hypertension, diabetes, or pre-diabetes can be included in the study program. Exercise and healthy nutritional diets can also help treat their existing health conditions.
Key exclusion criteria (2 listed)
- Significant comorbidities: Individuals with existing (e.g., severe or uncontrolled) medical illness, due to risk to aerobic exercise. This includes, but is not limited to, active ischemic heart disease, unstable angina, uncontrolled hypertension, or other conditions as determined by study physicians.
- High baseline activity: Individuals who have engaged in >4 hours intensive sports per week will be excluded. This population is deemed to be at very low risk, thus would likely derive minimal additional benefit from the intervention, and their inclusion could represent inefficient use of finite resources (e.g., DEXA scanning services).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupThe interventions include FUN Day, reinforcement FUN Day (2 months), nine mandatory structured exercise touchpoints, active chatbot with reminders/feedback/gamification, start and end DEXA scans (co-payment), 3-month assessment, ongoing incentives, and souvenirs at multiple points. | Behavioural | Intervention Group |
| Control GroupThe control group serves to establish baseline comparison with the intervention group to determine whether this new and intensive program is significantly better than the current standard of advice and basic tools. These include FUN Day, exercise videos, passive chatbot for data reporting, start and end DEXA scans (co-payment), 3-month assessment, and souvenirs at study start and end. | Behavioural | Control Group |
Primary outcome
Fracture risk
Time frame: To be reported monthly throughout study period (years 0-3) and annually after the study ends with long-term follow up (years 4-10).
It measures the incidence of fracture or adverse events, which is the ultimate clinical endpoint for osteoporosis prevention. Unit of measure: Count of fractures (per participant) Source: Electronic report/questionnaire and medical records for verification
17 secondary outcomes
Quality-Adjusted Life Years ("QALYs")
Time frame: Questionnaire to be taken at baseline (first FUN Day), post-intervention assessment day at 3-month, and annually during the study period (years 1-3). Long-term follow up if possible (annually after study ends, years 4-10).
Health literacy
Time frame: Questionnaire to be taken at baseline (during first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after study ends, years 4-10).
Change in bone mineral density (BMD)
Time frame: Scans to be done twice, once at baseline (after first FUN Day) and another scan between years 2-3 of the study.
Fall risk
Time frame: To be reported monthly throughout study period (years 0-3) and annually after the study ends with long-term follow up (years 4-10).
Upper body musculoskeletal strength
Time frame: Assessment to be taken at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Intervention group has additional measurements during reinforcement FUN Day before the 3-month assessment day.
Lower body musculoskeletal strength
Time frame: Assessment to be taken at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Intervention group has additional measurements during reinforcement FUN Day before the 3-month assessment day.
Balance
Time frame: Assessment to be taken at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Intervention group has additional measurements during reinforcement FUN Day before the 3-month assessment day.
Cardiovascular fitness
Time frame: Assessment to be taken at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Intervention group has additional measurements during reinforcement FUN Day before the 3-month assessment day.
Lean muscle mass distribution
Time frame: Assessment to be taken at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Intervention group has additional measurements during reinforcement FUN Day before the 3-month assessment day.
Exercise adherence
Time frame: To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
Exercise frequency
Time frame: To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
Physical activity level
Time frame: To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
Dietary habits (e.g. calcium and vitamin D)
Time frame: To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
Self-efficacy for exercise
Time frame: To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
Exercise tolerance
Time frame: To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
Chatbot engagement
Time frame: To be reported monthly throughout the 4-year study (years 0-4). Long-term follow up if possible.
Satisfaction on the program
Time frame: To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Yes. Anonymized dataset to be included as supplementary data in final publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian FANG principal investigator
Dept of Orthopaedics and Traumatology, Queen Mary Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Osteoporosis and Sarcopenia, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian FANG (+852 22554581, cfang@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture risk (time frame: To be reported monthly throughout study period (years 0-3) and annually after the study ends with long-term follow up (years 4-10).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.