Artificial Intelligence and mHealth to Determine the response to a LIfestyle intervention for the primary prevention of Osteoporosis and frailty fractures in Postmenopausal wome

Not Applicable

• Conditions: Osteoporosis; Post-menopause; Musculoskeletal - Osteoporosis; Reproductive Health and Childbirth - Menstruation and menopause

• Registration Number: ACTRN12622000953730
• Lead Sponsor: niversity of Seville

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-06
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 114

Inclusion Criteria

Inclusion criteria
- Postmenopausal women older than 40 years with greater than 8 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

Exclusion criteria
- Surgically induced menopause or cancer treatment.
- Low BMI (<18 kg / m2).
- Excessive alcohol consumption (greater than 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum beta-CrossLaps (ß-CTX) to assess bone resorption and P1NP, to assess bone remodeling[Baseline and 9 month post-intervention commencement.]