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Osteoporosis School

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ClinicalTrials.gov Identifier: NCT00224991
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : April 3, 2014
Sponsor:
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Osteoporosis Procedure: Intensive systematic information (osteoporosis school) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Effect of Training in Prevention of Falls, Compliance to Treatment and Quality of Life: A Randomized, Prospective Investigation.
Study Start Date : June 1999
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls Osteoporosis




Primary Outcome Measures :
  1. Fall frequency

Secondary Outcome Measures :
  1. Compliance
  2. Quality of life


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

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

Exclusion criteria:

- Physically or mental state that does not participation


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224991


Locations
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Denmark
Northern Orthopaedic Division, Klinik Hjoerring
Hjoerring, Northern Jutland, Denmark
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Investigators
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Principal Investigator: Annette Jaquet Northern Orthopaedic Division
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Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT00224991    
Other Study ID Numbers: ON-06-001-AJ
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: April 3, 2014
Last Verified: April 2014
Keywords provided by Northern Orthopaedic Division, Denmark:
osteoporosis
fall frequency
medical treatment
compliance
quality of life
systematic education
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases