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Osteoporosis and Sarcopenia Prevention in Middle-Aged Population (FORTIFY)

20 maja 2026 zaktualizowane przez: Prof. Christian Xinshuo Fang, The University of Hong Kong

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

8336

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Christian FANG
  • Numer telefonu: +852 22554581
  • E-mail: cfang@hku.hk

Lokalizacje studiów

  • Hongkong
      • Hong Kong, Hongkong
        • Queen Mary Hospital, The University of Hong Kong, Hong Kong,
        • Główny śledczy:
          • Christian FANG
        • Kontakt:
          • Christian FANG
          • Numer telefonu: +852 22554581
          • E-mail: cfang@hku.hk

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Tak

Opis

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Intervention Group
The intervention group will receive active, dynamic, and sustained support designed to build habits and maintain long-term healthy habits.
Behawioralne: Intervention Group
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.
Aktywny komparator: Control Group
The control group will receive passive and static support.
Behawioralne: Control Group
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Fracture risk
Ramy czasowe: 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
To be reported monthly throughout study period (years 0-3) and annually after the study ends with long-term follow up (years 4-10).

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Quality-Adjusted Life Years ("QALYs")
Ramy czasowe: 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).

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
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
Ramy czasowe: 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).

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.
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)
Ramy czasowe: Scans to be done twice, once at baseline (after first FUN Day) and another scan between years 2-3 of the study.

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
Scans to be done twice, once at baseline (after first FUN Day) and another scan between years 2-3 of the study.
Fall risk
Ramy czasowe: To be reported monthly throughout study period (years 0-3) and annually after the study ends with long-term follow up (years 4-10).

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
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
Ramy czasowe: 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.

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
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
Ramy czasowe: 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.

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
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
Ramy czasowe: 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.

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.
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
Ramy czasowe: 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.

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
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
Ramy czasowe: 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.

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
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
Ramy czasowe: 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).

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.
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
Ramy czasowe: 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).

Measured as the number of exercise sessions logged by the participant via chatbot.

Unit of measure: Number of sessions. Source: Electronic questionnaire and records
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
Ramy czasowe: 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).

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
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)
Ramy czasowe: 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).

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
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
Ramy czasowe: 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).

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.
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
Ramy czasowe: 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).

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
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
Ramy czasowe: To be reported monthly throughout the 4-year study (years 0-4). Long-term follow up if possible.

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.
To be reported monthly throughout the 4-year study (years 0-4). Long-term follow up if possible.
Satisfaction on the program
Ramy czasowe: 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).
Measured based on short, self-administered questionnaire by chatbot.
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).

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

The University of Hong Kong

Współpracownicy

The Hong Kong Jockey Club Charities Trust
The Family Planning Association of Hong Kong

Śledczy

  • Główny śledczy: Christian FANG, Dept of Orthopaedics and Traumatology, Queen Mary Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

31 maja 2030

Ukończenie studiów (Szacowany)

31 maja 2036

Daty rejestracji na studia

Pierwszy przesłany

7 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

20 maja 2026

Pierwszy wysłany (Rzeczywisty)

28 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

28 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

20 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • UW 26
  • 2026-0026-002 (Inny numer grantu/finansowania: The Hong Kong Jockey Club Charities Trust)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Anonymized dataset to be included as supplementary data in final publication

Ramy czasowe udostępniania IPD

Within 1 year of study completion

Kryteria dostępu do udostępniania IPD

Additional information available upon reasonable request of principal investigator

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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