SB: Promoting Bone Health in Women (NCT06843486) | Clinical Trial Compass
CompletedPhase 1/2
SB: Promoting Bone Health in Women
Portugal40 participantsStarted 2024-10-01
Plain-language 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.
Who can participate
Age range
60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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: Se…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bone mineral density (BMD)
Timeframe: From enrollment to the end of treatment at 6 months