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Completed

NCT Number: NCT00224991

Osteoporosis School

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.

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Key information

Conditions

Osteoporosis Behavior Bone Diseases Bone Diseases, Metabolic Health Behavior Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northern Orthopaedic Division, Klinik Hjoerring

Hjørring, Northern Jutland, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Physically or mental state that does not participation

Treatment and study plan

Intensive systematic information (osteoporosis school)

Procedure

Primary outcomes

  1. Fall frequency

Secondary outcomes

  1. Compliance

  2. Quality of life

Sponsors and collaborators

Lead sponsor

Northern Orthopaedic Division, Denmark

Other

Registry information

Official study title

Effect of Training in Prevention of Falls, Compliance to Treatment and Quality of Life: A Randomized, Prospective Investigation.

Important dates

Study start
1999
Study completion
2005
First posted
Sep 23, 2005
Registry last updated
Apr 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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