SB: Promoting Bone Health in Women

What this trial studies

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?

Conditions in scope

• Osteoporosis

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.

Who can join

Women only · Ages 60 Years and up

Inclusion criteria

• 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.

Exclusion criteria

• 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.

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: Completed
• Study type: Interventional
• Phase: PHASE1, PHASE2
• Start date: 2024-10-01
• Primary completion: 2025-05-02
• Last update posted: 2025-05-06
• First posted: 2025-02-25

Sponsor & contact

Lead sponsor: Instituto Politécnico de Bragança (Other)

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 mineral density (BMD) (From enrollment to the end of treatment at 6 months)
  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…

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