Osteoporosis, PostmenopausalDASH-OsteoNCT07120854
Evaluation of a Decision Analysis Model in the DASH-Osteo Decision Aid.
A study testing Decision aid with decision analysis model and Decision aid alone in people with Osteoporosis, Postmenopausal and Osteoporotic Fractures, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Postmenopausal, Osteoporotic Fractures, Diphosphonates
- What is being tested?
- Decision aid with decision analysis model and Decision aid alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteSpain
- Study dates
- 3 Apr 2025to 25 Feb 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Institut de Recerca Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
About this study
Official title: Evaluation of a Decision Analysis Model in a Decision Aid for Fracture Prevention in Postmenopausal Women: Randomized Clinical Trial.
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.
Read more
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.
Read the detailed description
Open-label, randomized, open-label, multicenter, three parallel arms, controlled clinical trial. It will be carried out in primary care centers belonging to the Autonomous Communities of Madrid and Catalonia.
The participants will be recruited in the medical consultation, by their family doctor, who will assess the fulfillment of the inclusion criteria a priori and according to eligibility, will offer the woman to participate in the study, informing her about the nature of the research. The informed consent form will be signed online, and the inclusion criteria will be verified by the participant herself when accessing the tool. Participation will be voluntary and does not entail economic incentives for the participants.
Random assignment will be simple following a 1:1:1 ratio to each group. To avoid possible contamination bias, randomization will be performed at the physician level, so that each professional will be randomized to one of the intervention groups so that he/she will apply exclusively one of the study's interventions to all the participants he/she recruits. Due to the characteristics of the interventions it will not be possible to blind the interveners and participants. After randomization, only the data analysts will be blinded to the randomization sequence. The central research team will primarily contact participants via email to send the decision aid tool link and questionnaire links. They will also follow up to ensure the completion of all data provided by the participants.
- Conditions
- Osteoporosis, Postmenopausal, Osteoporotic Fractures, Diphosphonates, Fracture Risk Assessment
- Being tested
- Decision aid with decision analysis model, Decision aid alone, Usual Care
- Keywords
- postmenopausal, osteoporotic fractures, primary prevention
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporotic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision aid with decision analysis modelOther
Women will use the web version of the decision aid tool. They will have a supporting video to help them how to navigate the tool during. They will be able to access the tool through a specific link that will be shared with them by their central research team via e-mail. Each woman is expected to use the web tool and select her preferences (utilities) regarding different health conditions (e.g. hip fracture). The results of the exercises will be received automatically at the central level (by institutional e-mail to the researcher responsible for the data a PDF file will be sent from the web). The research team at the central level will apply the decision analysis model, using information on the baseline fracture risk and preferences of each participant entered into the tool. The results of the decision analysis model will be delivered to the women directly by e-mail in plain language, so that they can make the final decision together with their general practitioner in a second visit.
Decision aid aloneOther
Participants will use the web tool. They will have a supporting video to help them how to navigate the tool during. They will be able to access the tool through a specific link that will be shared with them by the central research team via e-mail. Each woman is expected to navigate through the different functions of the web tool, at home or at a time other than the medical visit, and select her preferences (utilities) with respect to different health conditions (e.g. hip fracture). The women in this group would decide whether or not to take the pharmacological treatment based on the information provided by the tool but without the results of the decision analysis model described for the intervention group. Subsequently, those who wished to do so would make a final decision together with their physician at a second visit.
Usual CareOther
Also called Usual practice
Women in this group will receive standard clinical practice, without the use of the shared decision support tool or the decision analysis model or any other support. At the end of the visit, their physician will provide them with a link to access the assessment questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Decision aid plus decision analysis model | Experimental | Participants in this group will use DASH-Osteo decision aid plus the information in plain language, provided by a decision analysis model which will include the utilities provided by the same participants in the web- based tool, and will make a shared decision with their healthcare professional. Receives: Other: Decision aid with decision analysis model |
| Decision aid only | Experimental | Participants in this group will use DASH-osteo decision and will make a shared decision with their healthcare professional. Receives: Other: Decision aid alone |
| Control | Active comparator | Participants in this group will make a decision according to centre's usual practice Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional conflict
We will use the Decisional conflict scale (O'Connor 1998, updated 2010), to evaluate the uncertainty and the decision-making conflict across participants. It is a 16-item scale. IItems are summed, then multiplied by 25.
Scoring goes from 0 (low decisional conflict) to 100 (high decisional conflict). Patients with a total score >38 tend to delay decisions, whereas those with ≤ 25 tend to make decisions(1, 2)
- O'Connor AM. Validation of a Decisional Conflict Scale. Med Decis Making [Internet]. 1995 Feb;15(1):25-30. Available from: http://dx.doi.org/10.1177/0272989X9501500105
- Bunn H, O'Connor A. Validation of Client Decision-Making Instruments in the Context of Psychiatry. Can J Nurs Res [Internet]. 1996;28(3):13-27. Available from: https://pubmed.ncbi.nlm.nih.gov/8997937/
Measured: Decisional conflict will be measured one time up to 26 weeks, after participant use of the web-based tool.
Secondary outcomes (2)
Decision self-efficacy
Participants, self-confidence with the decision, will be measured with the Decision Self-efficacy scale (O'Connor 1995, updated 2002) a 11-item 5-point validated scale. Items are summed, then divided by 11 and then multiplied by 25.
Scores range from 0 ("extremely low self-efficacy") to 100 ("extremely high"). The scale is reliable and has been validated in different populations (1, 2).
- Bunn H, O'Connor A. Validation of Client Decision-Making Instruments in the Context of Psychiatry. Can J Nurs Res [Internet]. 1996;28(3):13-27.
- Galiana L, Sánchez-Ruiz J, Gómez-Salgado J, Larkin PJ, Sansó N. Validation of the Spanish Version of the Five-Item General Self-Efficacy (GSE) Scale in a Sample of Nursing Students: Evidence of Validity, Reliability, Longitudinal Invariance and Changes in General Self-Efficacy and Resilience in a Two-Wave Cross-Lagged Panel Model. Nurse Educ Pract [Internet]. 2024 Jan;74:103865.
Measured: Decision-Self-efficacy scale will be applied, up to 26 weeks, after using the decision aid tool.
Participant satisfaction with the decision process
We will measure participants satisfaction with the decision satisfaction scale from Holmes-Rovner 1996 (SWD). SWD scale is a 6-item validated scale scoring from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate greater satisfaction with the decision (1, 2, 3
- Holmes-Rovner M, Kroll J, Schmitt N, Rovner DR, Breer ML, Rothert ML, et al. Patient Satisfaction with Health Care Decisions: The Satisfaction with Decision Scale. Med Decis Making [Internet]. 1996 Feb;16(1):58-64. doi.org/10.1177/0272989X9601600114
- Wills CE, Holmes-Rovner M. Preliminary Validation of the Satisfaction With Decision scale with Depressed Primary Care Patients. Health Expect [Internet]. 2003 Jun;6(2):149-59. doi.org/10.1046/j.1369-6513.2003.00220.x
- Chabrera C, Areal J, Font A, Caro M, Bonet M, Zabalegui A. Versión española de la Satisfaction With Decision scale: adaptación transcultural, validez y fiabilidad. Enferm Clin [Internet]. 2015 May;25(3):117-23. dx.doi.org/10.1016/j.enfcli.2015.0
Measured: Satsfaction will be assessed up to 26 weeks, after participant's second visit with their physician.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start3 Apr 2025
- Primary completion20 Dec 2025 (estimated)
- Study completion25 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Catala de Salut, Servicio Madrileño de Salud, Madrid, Spain, Fondo de Investigacion Sanitaria
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120854
- Sponsor's protocol ID
- 24/202-P
- Acronym
- DASH-Osteo
- Status last verified
- Aug 2025
- First submitted
- 28 Jul 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No