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Completed

NCT Number: NCT05401968

Osteoporosis Patient Education in Denmark

In an effect evaluation the investigators will examine the effects of participating in osteoporosis patient education. An intervention group who have already participated in patient education will be compared to a matched control group who have not participated. Effects on quality of life, fractures, daily functional capacity, self-efficacy, psychological wellbeing, physical function, balance, falls, pain management, and adherence will be examined.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Public Health, University of Southern Denmark

Copenhagen, Denmark

About this study

In this quasi-experimental study the investigators will conduct an effect evaluation that compares an intervention group of osteoporosis patients who have participated in patient education in a municipality with a control group who have not participated.

The intervention group consists of citizens who have already participated in osteoporosis patient education from 2016 until 2020. The investigators have received information on the intervention group from the municipalities who store data on previous participants.

The control group will be extracted via the Danish Health Data Authority and consists of citizens who have not participated in osteoporosis patient education. For each individual in the intervention group one control will be matched regarding gender, age, diagnosis, time of diagnose, and type of fracture before the index date (i.e. the date the individual in the intervention group started on patient education).

The aim of the effect evaluation is to examine the effects of osteoporosis patient education on quality of life, fractures, daily functional capacity, self-efficacy, psychological wellbeing, physical function, balance, falls, pain management, and adherence.

Data is generated from a register extraction and a questionnaire-based survey. The questionnaire will include information on quality of life, daily functional capacity, self-efficacy, psychological wellbeing, physical function, balance, falls, and pain management. As far as possible validated questionnaires will be included to measure these outcomes. The register extraction will be made by the Danish Health Data Authority and include information on fractures and adherence.

All analyses are performed using Stata. In the analyses the investigators will compare the intervention group and the control group with regard to all outcomes. The covariates are selected on the basis of Directed Acyclic Graphs (DAG) and they include e.g. socioeconomic status, cohabitee status, and co-morbidity. The analysis will be completed on an intention to treat basis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • To participate in osteoporosis patient education in municipalities the participants should have osteoporosis or in few cases osteopenia.

Exclusion criteria

  • None though this may vary across municipalities

Treatment and study plan

Osteoporosis patient education

Behavioral

During osteoporosis patient education the participants get knowledge about e.g. osteoporosis, medication, and diet, and they participate in physical exercises. Though, differences between municipalities exist. The participants meet in groups and face-to-face.

Primary outcomes

  1. Differences in quality of life between intervention and control group

    Time frame: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)

    Measured with the 12-item Short-Form Health Survey of the Medical Outcomes Study (SF-12)

  2. Differences in clinical diagnosis of fracture between intervention and control group

    Time frame: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)

    Including hip, vertebral, forearm, and upper arm fractures registered in the National Patient Register

Secondary outcomes

  1. Differences in daily functional capacity between intervention and control group

    Time frame: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)

    Measured with questions from the European Health Interview Survey

  2. Differences in self-efficacy between intervention and control group

    Time frame: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)

    Measured with the questionnaire Self-Efficacy for Managing Chronic Disease 6-Item Scale (SES6G)

  3. Differences in psychological well-being between intervention and control group

    Time frame: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)

    Measured with the questionnaire Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)

  4. Differences in physical function between intervention and control group

    Time frame: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)

    Measured with questions from The Danish National Health Survey

  5. Differences in balance between intervention and control group

    Time frame: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)

    Measured with self-constructed, validated questions regarding problems with balance and balance confidence

  6. Differences in falls between intervention and control group

    Time frame: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)

    Measured with self-constructed, validated questions regarding number of falls and concerns about falling

  7. Differences in pain management between intervention and control group

    Time frame: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)

    Measured with the Pain Self-Efficacy Questionnaire (PSEQ)

  8. Differences in adherence by Medication Possession Ratio (MPR) between intervention and control group

    Time frame: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)

    Including adherence to alendronate and ibandronate attained from the Danish National Prescription Registry

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • National Research Center for Bone Health

Registry information

Official study title

Osteoporosis Patient Education in Danish Municipalities: an Evaluation of Existing Programs and Recommendations for Further Practice

Important dates

Study start
2022
Primary completion
2022
Study completion
2025
First posted
Jun 2, 2022
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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