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

Launched by UNIVERSITY OF SEVILLE · Dec 15, 2024

Keywords

ClinConnect Summary

This is a randomized study from Seville, Spain, looking at ways to prevent osteoporosis in postmenopausal women. Participants are randomly placed in one of two groups: (1) a lifestyle program that uses a wearable (Fitbit Versa) and a companion app (Weapom) to boost daily activity and impact-based movements for nine months, and (2) a usual-care control group receiving general health advice. The study focuses on whether the activity program can improve bone health and related outcomes, without blinding participants (but outcome assessors are kept unaware of group assignment to reduce bias).

If you join, you would start with screening to confirm you’re a postmenopausal woman over 40 who has been inactive for a while. Over the 9 months, researchers will measure several things at the start and end: bone density in the lower spine and hip, blood markers of bone turnover, body composition, quality of life, menopause symptoms, balance and mobility, strength, walking speed, and daily activity. You’ll wear a device to track activity for about a week and answer lifestyle and diet questions. In the lifestyle group, you’ll have target goals such as steps, daily jumps, and pace, with feedback from the app; in the control group you’ll get standard lifestyle advice. Vitamin D or calcium may be given if needed. The study aims to see if this non-drug approach can prevent osteoporosis and reduce fracture risk, and to explore how wearable tech might support long-term healthy habits.

Gender

FEMALE

Eligibility criteria

• 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).
• • Upper or lower limb fracture in the last 6 months.
• • Mobility problems or requiring assistance to walk.
• • Participation in physical exercise programs in the 6 months prior to the study.
• • Regular use of glucocorticoids or hormone replacement therapy in the past 3 months.
• • Unwillingness to complete the study requirements.