Osteoporosis and Sarcopenia Prevention in Middle-Aged Population

Osteoporosis and Sarcopenia Prevention in Middle-Aged Population

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.

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.

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).