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Completed

NCT Number: NCT01600547

Odense Fallers and Osteoporosis Study

Osteoporosis and falls occur with increasing frequency among the elderly. Osteoporosis and fall increases the risk of fracture. Falls in the elderly are associated with a high morbidity and mortality with potentially life-threatening consequences of falls including fractures. Besides fracture fall may cause long term problems such as disability fear of falling and loss of independence. Today osteoporosis is diagnosed by bone scan of the hip and spine. The investigators want to investigate whether other more accessible and less expensive testing methods can be used to diagnose osteoporosis. Additionally, the investigators will examine the incidence of osteoporosis among the elderly in the municipality of Odense. Finally, the investigators would like to investigate the association between factors that can lead to falls and to investigate the performance of older and whether there are changes in functional ability over time.

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Key information

Conditions

Accidental Falls Bone Diseases Bone Diseases, Metabolic Disability Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

65 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Odense University Hospital Geriatric department

Odense C, 5000, Denmark

About this study

Study Objectives

  • To define the prevalence of osteoporosis in a falls clinic population, and compare it with two aged matched control groups - fallers not attending the falls clinic and non-fallers.
  • To evaluate the usefulness of peripheral bone scanning techniques in a falls clinic population.
  • To determine the prevalence of vertebral fractures in a falls clinic population and compare it with two aged matched control groups - fallers not attending the falls clinic and non-fallers
  • To investigate functioning, disability, health related quality of life and perceived need for rehabilitation in a falls clinic population including variation in a one year period, and compare it with two aged matched control groups - fallers not attending the falls clinic and non-fallers.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Women aged 65 years or over attending the falls clinic

*(There will be no upper age limit to recruitment).

  • Those capable of giving Informed consent.

Exclusion criteria

  • Patients under the age of 65 years.
  • Men.
  • Patients unwilling to give informed consent.
  • Cognitively impaired people who are not capable of giving consent.
  • Patients who are not mobile enough to be helped onto a DXA scan table with help

Treatment and study plan

Primary outcomes

  1. Bone mineral density using DXA of hip and spine regions (Hologic machine)

    Time frame: baseline

  2. Prevalence of vertebral fractures using instant vertebral assessment mode (IVA) of the DXA machine (Hologic machine)

    Time frame: baseline

  3. Bone mineral density of the phalanges using radiographic absorptiometry (Alara Metriscan machine)

    Time frame: baseline

  4. Broad band ultrasound attenuation of the heel using the heel ultrasound machine (Lunar Achilles machine)

    Time frame: baseline

  5. Fall incidences

    Time frame: one year

  6. Mental health state

    Time frame: one year

    Meausered by Mini Mental State Examination (MMSE)

  7. Health related quality of life

    Time frame: one year

    Self Reporting Questionnaire will be used

  8. Perceived need

    Time frame: one year

    Self Reporting Questionnaire

  9. Basis mobility

    Time frame: One year

    Time up and go, Chair stand, Bergs balance scale, Avlunds scale, gait speed and dual-task will be used

  10. Fear of falling

    Time frame: One year

    The Falls Efficacy scale - international will be used

  11. Muscle strength in upper and lower extremities

    Time frame: One year

    A dynamometer will be used

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Odense University Hospital

Registry information

Acronym: OFOS

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
May 17, 2012
Registry last updated
Dec 8, 2014

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

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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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