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

What this trial studies

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.

Conditions in scope

• Osteoporosis in Post-menopausal Women
• Prevention
• Exercise
• Physical Activity
• Wearable Devices

Interventions

• Weapom Lifestyle Intervention to measure bone impacts using a Fitbit Versa wearable device and the Weapom App. (Behavioral) — 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…

Who can join

Women only · Ages 40 Years and up · Accepts healthy volunteers.

Inclusion criteria

• Postmenopausal women older than 40 years with ≤ 10 years after menopause ("early postmenopausal women").
• Sedentary women (defined as not performing regular physical activity greater than 150 min of moderate-vigorous physical activity per week in the last six months).
• Willing to give consent to participate in the study.

Exclusion criteria

• Surgically induced menopause or cancer treatment.
• Low BMI (\<18 kg / m2).
• Excessive alcohol consumption (≥3 drinks per day).
• Smoker
• Unstable cardiovascular disease.
• Rheumatoid arthritis.
• Chronic kidney disease
• Diagnosis of conditions that alter bone metabolism (hypo/hypercalcemia, hyperthyroidism, hypo/hypergonadism).

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Enrolling by invitation
• Study type: Interventional
• Phase: N/A
• Start date: 2023-09-01
• Primary completion: 2025-03-01
• Last update posted: 2024-12-19
• First posted: 2024-12-19

Sponsor & contact

Lead sponsor: University of Seville (Other)

Collaborators: Hospitales Universitarios Virgen del Rocío

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• 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…
• 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…

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