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NCT06603545Not yet recruiting

The Effect of Digital Education for Osteoporosis Patients on Fracture Risk and Related Health Outcomes.

The Effect of Digital Education for Osteoporosis Patients on Fracture Risk and Related Health Outcomes in Older Swedish Men and Women.

Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

A digital education for osteoporosis patients (DEOP) has been developed and tested on patients in Region Vastra Gotaland, Sweden. Currently, the evidence regarding the efficacy of patient education on fracture risk, medication adherence, injurious falls, levels of physical activity, and diet is insufficient. Most patients with osteoporosis in Sweden are diagnosed and treated in primary care, where the knowledge about osteoporosis is often very limited. Thus, in general, osteoporosis patients are not sufficiently informed before receiving a treatment recommendation. This randomized controlled trial aims to investigate if DEOP vs. standard care can reduce the incidence of fracture in older women and men, and if the intervention leads to better adherence to osteoporosis medication, higher quality of life, increased physical activity, and enhanced diet. The primary objective is to investigate if DEOP compared to standard care (without DEOP), can reduce the incidence of clinical fractures in men and women, over the age of 65 years, without previous osteoporosis medication the last year, who have been recommended osteoporosis treatment after a DXA scan and assessment of clinical risk factors at an osteoporosis clinic. The secondary objectives are to investigate if DEOP compared to standard care (without DEOP), can reduce the incidence of injurious falls, have positive effects on adherence to osteoporosis medication, positively affect diet (calcium and vitamin D intake), physical activity, and improve quality of life in men and women, over the age of 65 years, without previous osteoporosis medication the last year, who have been recommended osteoporosis treatment after a DXA scan and assessment of clinical risk factors at an osteoporosis clinic. Study design: randomized multicentre clinical trial. Patients over the age of 65 visiting an osteoporosis unit for a bone density scan (DXA) will be asked to participate in the study. The participants will be randomized to one of two arms where one arm will be invited to DEOP and the other arm will receive standard care, without DEOP.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
2640 (estimated)
First submitted
11 Sept 2024
Start date
1 Sept 2024
Primary completion date
31 Dec 2029
Lead sponsor
Sahlgrenska University Hospital
Diseases
Osteoporosis
NCT number
NCT06603545

What you commit to

  • Study type: Interventional
  • Planned participants: 2640
  • From 1 Sept 2024 to the primary completion date, 31 Dec 2029
  • No sites listed in no 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

  • Patients with previous osteoporosis medication the last year.

Who the study is looking for

  • Patients visiting an osteoporosis unit, 65 years and older.
  • Ability to understand and follow study instructions.
  • Signed informed consent.
  • Have been recommended pharmacological osteoporosis treatment after a clinical evaluation including a DXA-scan and assessment of fracture risk at an osteoporosis clinic.
  • Have access to www.1177.se.

Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.