Osteoporosis and Sarcopenia Prevention in Middle-Aged Population

NCT07611097 | Not Yet Recruiting DMC

• 2 other identifiers: UW 262026-0026-002
• Study Type: interventional
• Target: 8,336
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Osteoporosis; Sarcopenia

Keywords

Randomized Controlled Trial; Middle-Aged Population; Osteoporosis Prevention; Sarcopenia Prevention; AI Chatbot; DEXA Alternative

Outcome Measures

Primary Outcomes (1)

• 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

  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")

  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

  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)

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

• Fall risk

  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

  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.

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group will receive active, dynamic, and sustained support designed to build habits and maintain long-term healthy habits.

Behavioral: Intervention Group

Control Group

ACTIVE COMPARATOR

The control group will receive passive and static support.

Behavioral: Control Group

Interventions

Intervention Group BEHAVIORAL

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.

Intervention Group

Control Group BEHAVIORAL

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.

Control Group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead
• The Hong Kong Jockey Club Charities Trust: collaborator
• The Family Planning Association of Hong Kong: collaborator

Study Sites (1)

Queen Mary Hospital, The University of Hong Kong, Hong Kong,

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Osteoporosis; Sarcopenia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Christian FANG

  Dept of Orthopaedics and Traumatology, Queen Mary Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian FANG

CONTACT

+852 22554581; cfang@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 28, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): May 31, 2036
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within 1 year of study completion
• Access Criteria: Additional information available upon reasonable request of principal investigator

Locations

HK (1)