Osteoporosis School

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

Tracking Information

• First Submitted Date: September 21, 2005
• First Posted Date: September 23, 2005
• Last Update Posted Date: April 3, 2014
• Study Start Date: June 1999
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: October 17, 2012): Fall frequency
• Original Primary Outcome Measures (submitted: September 21, 2005): Fall freqency

Current Secondary Outcome Measures (submitted: September 21, 2005)

• Compliance
• Quality of life

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Osteoporosis School
• Official Title: Effect of Training in Prevention of Falls, Compliance to Treatment and Quality of Life: A Randomized, Prospective Investigation.

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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label)
• Condition: Osteoporosis
• Intervention: Procedure: Intensive systematic information (osteoporosis school)
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: September 21, 2005): 350
• Original Enrollment: Same as current
• Study Completion Date: June 2005
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT00224991
• Other Study ID Numbers: ON-06-001-AJ
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Northern Orthopaedic Division, Denmark
• Study Sponsor: Northern Orthopaedic Division, Denmark
• Collaborators: Not Provided

Investigators

• Principal Investigator: Annette Jaquet; Northern Orthopaedic Division

• PRS Account: Northern Orthopaedic Division, Denmark
• Verification Date: April 2014