Evaluation of a Decision Analysis Model in the DASH-Osteo Decision Aid. (NCT07120854) | Clinical Trial Compass
By InvitationNot Applicable
Evaluation of a Decision Analysis Model in the DASH-Osteo Decision Aid.
Spain114 participantsStarted 2025-04-03
Plain-language summary
Fragility fractures, often caused by low bone mineral density, are a major health concern for postmenopausal women. One way to prevent these fractures is by taking medication, but deciding whether to start treatment can be difficult due to potential risks and side effects.
This study will test a web-based tool designed to help women make informed decisions about fracture prevention treatment. The tool provides information about the benefits and risks of treatment. Some women in the study will also receive additional support through a decision analysis report, which helps weigh different factors when making a choice.
The study will examine whether using this tool improves decision-making, increases confidence in making a choice, and enhances satisfaction with the decision. It will also explore what factors influence women's decisions and at what level of risk they choose to start treatment.
By understanding how decision aids impact choices, researchers aim to improve the way healthcare providers support patients in making informed decisions about their health.
Who can participate
Age range
50 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:
* Postmenopausal women older than 50 years
* No medical history of fragility fractures
* With or without a BMD measurement performed
* Having been considered candidates to pharmacological treatment prevention for fragility fractures.
* A 10 year fracture risk assessment according to FRAX for Major fracture \>5%.
Exclusion Criteria:
* women with a history of fragility fracture
* being treated with bisphosphonates or other osteoporosis drugs (except for vitamin D and calcium supplements
* suffer from serious concomitant pathologies (cancer, chronic renal insufficiency, etc.)
* women under permanent treatment with glucocorticoids.
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
Decisional conflict
Timeframe: Decisional conflict will be measured one time up to 26 weeks, after participant use of the web-based tool.
Trial details
NCT IDNCT07120854
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau