Osteoporosis School

April 2, 2014 updated by: Northern Orthopaedic Division, Denmark

Effect of Training in Prevention of Falls, Compliance to Treatment and Quality of Life: A Randomized, Prospective Investigation.

The purpose of this study is to investigate the efficacy of systematic education (osteoporosis school) on fall frequency, compliance and quality of life of a group of patients more than fifty years of age.

Hypothetically, systematic information can increase compliance to the medical treatment, decrease the frequency of falls and increase the quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In most randomized trials compliance to medical treatment in osteoporosis is very high, but compliance tends to be considerably inferior in routine treatment compared to scientific trials. This fact is caused by a narrow selection of motivated patients in the randomized trials. Perhaps, the information given to the patients in scientific trials is more thorough than information given in a routine setting.

There are no trials available that document that compliance to medical treatment of patients with osteoporosis can be increased by intensive systematic information.

Change of lifestyle is an important part in the treatment of these patients. The patients are encouraged to eat more healthy food combined with an intake of calcium and vitamins, reduction of alcohol and tobacco consumption if needed and prevention of fall incidence through changes in the house.

The quality of life is often reduced, partly due to chronic pain, altered social status, physical handicap and partly due to the heavy knowledge of having a chronic decease.

Adaption to the last-mentioned factors can possibly lead to a considerably better quality of life in spite of the unchanged physical handicap.

Randomized trials on efficacy of systematic patient education has in general been positive in other contexts. Young patients with diabetes offered coping skills training have therefore a better metabolic control and quality of life.

No similar randomized trials are available on the efficacy of a systematic education program in osteoporosis.

Study Type

Interventional

Enrollment

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Northern Jutland
      • Hjoerring, Northern Jutland, Denmark
        • Northern Orthopaedic Division, Klinik Hjoerring

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • fracture caused by osteoporosis
  • fifty years or more of age
  • informed consent

Exclusion criteria:

- Physically or mental state that does not participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Fall frequency

Secondary Outcome Measures

Outcome Measure
Quality of life
Compliance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Orthopaedic Division, Denmark

Investigators

  • Principal Investigator: Annette Jaquet, Northern Orthopaedic Division

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1999

Primary Completion

December 7, 2022

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

September 21, 2005

First Submitted That Met QC Criteria

September 21, 2005

First Posted (Estimate)

September 23, 2005

Study Record Updates

Last Update Posted (Estimate)

April 3, 2014

Last Update Submitted That Met QC Criteria

April 2, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ON-06-001-AJ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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