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| Sponsored by: |
Northern Orthopaedic Division, Denmark |
|---|---|
| Information provided by: | Northern Orthopaedic Division, Denmark |
| ClinicalTrials.gov Identifier: | NCT00224991 |
Purpose
The purpose of this study is to investigate the efficacy of systematic education (osteoporosis school) on fall frequency, compliance and quality of life, to 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.
| Condition | Intervention |
|---|---|
|
Osteoporosis |
Procedure: Intensive systematic information (osteoporosis school) |
| Study Type: | Interventional |
| Study Design: | Educational/Counseling/Training, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Effect of Training in Prevention of Falls, Compliance to Treatment and Quality of Life: A Randomized, Prospective Investigation. |
| Estimated Enrollment: | 350 |
| Study Start Date: | June 1999 |
| Estimated Study Completion Date: | June 2005 |
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 can be due to narrow selection of motivated patients in the randomized trials, but perhaps the information given to the patients in scientific trials is more thorough than that given in a rutine setting.
There are no trials available on whether compliance to medical treatment of patients with osteoporosis can be increased by intensive systematic information.
The change of lifestyle is an important part of the treatment of these patients. The patients are encouraged to eat more healthy food including calcium and vitamine-D intake, reduction of alcohol and tobaco consumtion if needed and prevention of fall incidense 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 can perhaps lead to 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, has thus a better metabolic control and quality of life.
No similar randomized trials are available on the efficacy of a systematic education program in osteoporosis.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
fracture caused by osteoporosis, fifty years or more of age, informed consent -
Exclusion Criteria:
physically or mentally state that doesn't allow participation
-
Contacts and Locations| Denmark, Northern Jutland | |
| Northern Orthopaedic Division, Klinik Hjoerring | |
| Hjoerring, Northern Jutland, Denmark | |
| Principal Investigator: | Annette Jaquet | Northern Orthopaedic Division |
More Information
| Study ID Numbers: | ON-06-001-AJ |
| Study First Received: | September 21, 2005 |
| Last Updated: | March 13, 2007 |
| ClinicalTrials.gov Identifier: | NCT00224991 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
|
osteoporosis fall frequency medical treatment |
comliance quality of life systematic education |
|
Musculoskeletal Diseases Quality of Life Osteoporosis Bone Diseases, Metabolic Bone Diseases |
