SB: Promoting Bone Health in Women

NCT06843486 | Completed Phase 1

• 1 other identifier: 755614
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to find out whether multicomponent training works to treat osteoporosis in women. It will also find out about the safety of multicomponent training in this specific population. The main questions it aims to answer are: Does multicomponent training improve bone mineral density in women? What are the benefits of multicomponent training? The researchers will compare the intervention group (MTC) with a control group that did not perform any type of intervention, to see if MTC training works in treating bone mineral density in women. The participants will: Perform MTC training for 6 months with a frequency of 3 times a week in sessions of 40-60 minutes. While the control group will carry out their daily activities normally and will only attend on the days of the assessments.

Conditions

Osteoporosis

Keywords

Osteoporosis; Womens; Menopause

Outcome Measures

Primary Outcomes (1)

• Bone mineral density (BMD)

  Bone mineral density (BMD), measured in g/cm², assesses regions such as the lumbar spine, proximal femur, and total body. It is used to diagnose and monitor osteopenia and osteoporosis based on WHO criteria. The T-score, expressed in standard deviations (SD), compares the patient's BMD to that of a young, healthy population, classifying osteopenia (T-score -1.0 to -2.5 SD) and osteoporosis (T-score ≤ -2.5 SD). The Z-score compares BMD to age- and sex-matched averages, aiding in identifying secondary causes of osteoporosis. Dual-energy X-ray absorptiometry (DXA) is the standard method for measuring BMD. Additionally, DXA provides body composition analysis, offering data on bone mass (grams), lean mass (grams/kilograms), and body fat percentage (%). These parameters enable a comprehensive assessment of musculoskeletal health and nutritional status.

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (6)

• Lower Limb Strength

  From enrollment to the end of treatment at 6 months

• Upper Limb Strength

  From enrollment to the end of treatment at 6 months

• Lower Limb Flexibility

  From enrollment to the end of treatment at 6 months

• Upper Limb Flexibility

  From enrollment to the end of treatment at 6 months

• Agility/Balance

  From enrollment to the end of treatment at 6 months

Study Arms (2)

Control Group

NO INTERVENTION

The group will not receive any type of intervention

Multicomponent Exercise

EXPERIMENTAL

Participants receive an intervention (a multi-component exercise program).

Other: Multicomponent Exercise

Interventions

Multicomponent Exercise OTHER

Training sessions will include aerobic, resistance, balance and flexibility exercises, following the American College of Sports Medicine (ACSM) guidelines for osteoporosis prevention.

Multicomponent Exercise

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range: Women over 65 years of age. Clinical diagnosis:
• Previous diagnosis of osteoporosis confirmed by DXA (T-score between -1.0 and -2.5 for osteopenia and ≤ -2.5 for osteoporosis).
• Ability to exercise: Medical clearance to participate in the exercise program. and ability to perform moderate-impact physical activities and muscular endurance.
• Level of physical activity: Sedentary women or women with low to moderate levels of physical activity, without regular practice of specific exercises for bone health in the last 6 months.
• Agreement to the study: Signing of the Free and Informed Consent Form (FICF) and availability to participate in the training program for 6 months.

You may not qualify if:

• Advanced clinical diagnosis: T-score below -3.0 (severe osteoporosis with high risk of fractures); History of severe osteoporotic fracture in the last 6 months.
• Associated diseases or conditions: Uncontrolled metabolic or endocrine diseases that affect bone metabolism (e.g., hyperparathyroidism, Cushing's syndrome, decompensated diabetes); Active chronic inflammatory diseases (e.g., advanced rheumatoid arthritis, systemic lupus erythematosus); Severe chronic renal failure (stages 4 or 5).
• Use of specific medications in the last 12 months: Bisphosphonates, denosumab, teriparatide or strontium ranelate; High-dose glucocorticoids (\>5 mg/day for more than 3 months); Recent hormone therapy for osteoporosis.
• Orthopedic or neuromuscular conditions: Severe functional limitation that prevents the performance of physical exercises (e.g., severe osteoarthritis, advanced joint instability, neurological sequelae of stroke); Orthopedic surgery in the last 6 months or indication for elective surgery for the spine or lower limbs.
• Factors that limit adherence to the study: Difficulty in moving that prevents participation in in-person training (for the in-person MCT group); Lack of availability to attend sessions or follow the study protocol; History of low adherence to previous health-related interventions.
• Participation in another clinical study: Women enrolled in clinical trials that may interfere with the results of the study or adherence to the protocol.

Sponsors & Collaborators

• Instituto Politécnico de Bragança: lead

Study Sites (1)

Instituto Politécnico de Bragança

Bragança, Braganza District, 5300-253, Portugal

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 25, 2025
• Study Start: October 1, 2024
• Primary Completion: May 2, 2025
• Study Completion: May 2, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

PT (1)