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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorSahlgrenska University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Patients with previous osteoporosis medication the last year.

Trial design

Treatments tested in this trial

  • Digital education for osteoporosis patients

Treatment groups

2,640 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Sahlgrenska University Hospital

Lead sponsor

Uppsala University Hospital

Collaborator

Region Stockholm

Collaborator

Västernorrland County Council, Sweden

Collaborator

Region Västerbotten

Collaborator

Region Skane

Collaborator

Norrbottens Lans Landsting

Collaborator