Development of a Wearable Device for Osteoporosis Prevention and Fracture Risk Reduction in Women

Condition(s) studied

Investigational drug(s) / intervention(s)

Weapom Lifestyle Intervention to measure bone impacts using a Fitbit Versa wearable device and the Weapom App.: A. Program to increase physical activity and impacts For the intervention, a biosensor -wearable device- (Fitbit Versa) will be used. The device is linked to an App (Weapom) that will allow users to quantify the number of steps (including the rate of steps per minute), the impacts and their intensity. Users will be given feedback from the application on the level of achievement of the objectives proposed in the impact program (EV). It will be proposed to achieve 50 vertical and multidirectional jumps per day (milestone 1. The number of jumps\> 3.9 G per day will be recorded 28, divided between 3-5 sets of 10-20 repetitions with a minimum 1-2 minute rest between sets. A frequency between 4-7 days per week will be used. In the same way, it will be recommended to reach 10,000 steps per day (milestone 2. The number of daily steps will be recorded) and, as far as possible, at a rapid pace (milestone 3. The number of daily minutes walking at a pace over 110 steps/minute will be r

Study summary

This project aims to determine the impact on bone health of:

A lifestyle intervention promoting impact-based activities and physical activity for nine months.

The same program enhanced with home-based strength training. A control group without supervision, continuing with standard care. The study will evaluate the persistence of changes after these interventions during a 12-week follow-up. By employing diverse strategies, the project seeks to identify barriers and facilitators to using technology for promoting healthy lifestyles in this demographic. Additionally, it will, for the first time in Spain, establish predictive models to assess the efficacy of non-pharmacological interventions in osteoporosis prevention, in collaboration with the public health system. These models will also predict adherence to technology-based behavioral interventions.

ELIGIBILITY CRITERIA

Eligible Participants:

Postmenopausal women aged \>40 years, within 8 years post-menopause. Sedentary lifestyle. Willingness to provide informed consent.

Exclusion Criteria:

Surgically induced menopause or cancer treatment. Low BMI (\<18 kg/m²). Excessive alcohol consumption (≥3 drinks/day). Smoking. Unstable cardiovascular disease, rheumatoid arthritis, chronic kidney disease. Diagnosed conditions altering bone metabolism (e.g., hyperthyroidism). Recent fractures or mobility limitations. Recent engagement in structured physical activity programs. Recent use of glucocorticoids or hormone replacement therapy. VARIABLES TO BE MONITORED Body Composition: Lean mass, fat mass, bone mass, and waist circumference. Bone Health: Bone density of lumbar vertebrae and femur via densitometry and microarchitecture evaluation using quantitative CT.

Biomarkers: Assessment of bone resorption and remodeling markers. Physical Function: Functional assessments (e.g., gait speed, jumping ability, lower limb strength).

Physical Activity: Objectively monitored with accelerometers, analyzing sedentary, light, and moderate-to-vigorous activities.

Nutritional Intake: Monitored using dietary recall tools. Quality of Life: Assessed using the Menopause Rating Scale (MRS). TRAINING PROTOCOL

A. Impact-Based Physical Activity Program:

Participants will utilize a validated biosensor (Muvone®) to track steps and impacts, targeting 50 multidirectional jumps and 10,000 steps per day, emphasizing brisk walking.

B. Home-Based Strength Training Program:

Two weekly sessions, progressing from 20 to 42 minutes, targeting major muscle groups (e.g., squats, hip extensions). Sessions include warm-ups, multi-joint exercises, and recovery periods.

C. Control Group:

Participants receive general advice on physical activity and nutrition without supervised programs or app access.

FOLLOW-UP After 36 weeks, participants will resume daily routines without app feedback. At the 12-week follow-up, they will return for questionnaires and physical assessments.

This structured approach ensures rigorous evaluation and facilitates integration of findings into public health strategies.

Eligibility

Primary outcome measure(s)

• Bone density — Pre (week 0) and post (week 36).
  The BMD (g/cm2) of the lumbar vertebrae (L1-L4) and femur of the right leg (femoral neck, Ward's triangle, and greater trochanter) will be analyzed by a specialist technician outside the study. Values will be converted to T-score and Z-score based on the reference values for a Caucasian female and the bone density of the Spanish population, respectively. The device will be calibrated daily using a phantom.
• Bone biomarkers — Pre (week 0) and post (week 36).
  To avoid diurnal variation, fasting blood samples will be collected between 8:00 and 10:00 in vacutainer tubes and aliquots will be stored frozen at -80ºC until analysis. Serum Β-CrossLaps (β-CTX) to assess bone resorption and P1NP, to assess bone remodeling, will be measured both at baseline and at 36 weeks by chemiluminescence (ECLIA) on a Modular Analytics E170 analyzer (Roche Diagnostics, Switzerland).

Trial sites (1)

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