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|ClinicalTrials.gov Identifier: NCT00224991|
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : April 3, 2014
|First Submitted Date ICMJE||September 21, 2005|
|First Posted Date ICMJE||September 23, 2005|
|Last Update Posted Date||April 3, 2014|
|Study Start Date ICMJE||June 1999|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Osteoporosis School|
|Official Title ICMJE||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.
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 ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|Intervention ICMJE||Procedure: Intensive systematic information (osteoporosis school)|
|Study Arms ICMJE||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date ICMJE||June 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
- Physically or mental state that does not participation
|Ages ICMJE||50 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Denmark|
|Removed Location Countries|
|NCT Number ICMJE||NCT00224991|
|Other Study ID Numbers ICMJE||ON-06-001-AJ|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||Northern Orthopaedic Division, Denmark|
|Study Sponsor ICMJE||Northern Orthopaedic Division, Denmark|
|Collaborators ICMJE||Not Provided|
|PRS Account||Northern Orthopaedic Division, Denmark|
|Verification Date||April 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP