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Systematic Prevention of Further Fractures in Patients With Hip Fractures and Osteoporosis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00414830
Recruitment Status : Unknown
Verified April 2008 by Odense University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : December 22, 2006
Last Update Posted : May 7, 2008
National Board of Health, Denmark
University of Southern Denmark
Merck Sharp & Dohme Corp.
Information provided by:
Odense University Hospital

Brief Summary:
The purpose of this study is to determine if prevention of further fractures is possible through systematic evaluation for osteoporosis in patients with recent hip fracture

Condition or disease
Hip Fracture Osteoporosis

Detailed Description:

Osteoporosis is a common disease characterized by an increased risk of fracture. Furthermore recent studies has revealed that patients with fractures have increased risk of renewed fracture. Most fractures in the elderly are partly attributable to osteoporosis. The most severe of these shown to be the hip fracture (HFx) which increase mortality and decrease health related quality of life and has major impact on the level of national health service. Solid evidence is available showing several interventions to reduce the risk of osteoporotic fractures. In spite of this only few HFx patients are offered examination or treatment for osteoporosis and very rare this happens on a routine basis.

In the county of Funen and Ribe in Denmark the departments of Endocrinology and Orthopedic Surgery at Odense University Hospital and Hospital of South Western Jutland therefore initiated a fracture discharge program as part of a health technology assessment (HTA) study offering evaluation for osteoporosis to HFx patients. Evaluation consists of Duel Energy X-ray Absorptiometry, Instant Vertebral Assessment, a biochemical panel, and clinical assessment followed by specific anti-osteoporotic treatment as appropriate.

The HTA study is designed as a longitudinal cohort study of patients admitted to the participating departments with a low energy HFx. Inclusion started January first 2005 and ends December 31. 2006. After the last inclusion the follow up of the last patient are set to 2 years. In the study period data will be collected on subsequent fractures, epidemiological and demographic factors, questionnaires on quality of life, and register data on mortality, use of medication, and use of health services. The control group consists of patients admitted to any other hospital in the two participating counties who are not given this systematic evaluation for osteoporosis on a routine basis.

The HTA report will provide data to suggest if a systematic offer of evaluation and treatment of osteoporosis in HFx patients:

can reduce further fractures is accepted by the majority of patients can increase the amount of life years by decreasing mortality can increase quality of life by reducing the amount of fractures is cost effective for the health care providers

Study Type : Observational
Estimated Enrollment : 600 participants
Time Perspective: Prospective
Study Start Date : January 2005
Estimated Study Completion Date : September 2009

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • admitted to the department of orthopedic surgery at Odense University Hospital or Hospital of South Western Jutland with a low energy hip fracture

Exclusion Criteria:

  • dementia
  • pathological fracture
  • severe comorbidity
  • not wanting to participate

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 identifier (NCT number): NCT00414830

Odense University Hospital, Department og Endocrinology
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
National Board of Health, Denmark
University of Southern Denmark
Merck Sharp & Dohme Corp.
Principal Investigator: Kim T Brixen, M.D.,PH.D. Odense University Hospital Identifier: NCT00414830     History of Changes
Other Study ID Numbers: 023
First Posted: December 22, 2006    Key Record Dates
Last Update Posted: May 7, 2008
Last Verified: April 2008

Keywords provided by Odense University Hospital:
health technology assessment
population based

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Femoral Fractures
Hip Injuries
Leg Injuries