NCT06843486CompletedPhase 1/2
SB: Promoting Bone Health in Women
Strong Bones: Promoting Bone Health and Quality of Life in Postmenopausal Women.
Source: ClinicalTrials.gov · Last updated 6 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 5 Feb 2025
- Start date
- 1 Oct 2024
- Primary completion date
- 2 May 2025
- Lead sponsor
- Instituto Politécnico de Bragança
- Diseases
- Osteoporosis
- NCT number
- NCT06843486
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 40
- From 1 Oct 2024 to the primary completion date, 2 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- 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).
- 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.
Other
- Participation in another clinical study: Women enrolled in clinical trials that may interfere with the results of the study or adherence to the protocol.
Who the study is looking for
- 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.
Age in the registry: 60 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Politécnico de Bragança Coordinator of this site? Confirm its status | Bragança | Portugal | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.