Osteoporosis Clinical Trial
— OFOSOfficial title:
Odense Fallers and Osteoporosis Study
Verified date | December 2014 |
Source | University of Southern Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: National Board of Health |
Study type | Observational |
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.
Status | Completed |
Enrollment | 322 |
Est. completion date | December 2014 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 65 Years and older |
Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Denmark | Odense University Hospital Geriatric department | Odense C |
Lead Sponsor | Collaborator |
---|---|
University of Southern Denmark | Odense University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone mineral density using DXA of hip and spine regions (Hologic machine) | baseline | No | |
Primary | Prevalence of vertebral fractures using instant vertebral assessment mode (IVA) of the DXA machine (Hologic machine) | baseline | No | |
Primary | Bone mineral density of the phalanges using radiographic absorptiometry (Alara Metriscan machine) | baseline | No | |
Primary | Broad band ultrasound attenuation of the heel using the heel ultrasound machine (Lunar Achilles machine) | baseline | No | |
Primary | Fall incidences | one year | No | |
Primary | Mental health state | Meausered by Mini Mental State Examination (MMSE) | one year | No |
Primary | Health related quality of life | Self Reporting Questionnaire will be used | one year | No |
Primary | Perceived need | Self Reporting Questionnaire | one year | No |
Primary | Basis mobility | Time up and go, Chair stand, Bergs balance scale, Avlunds scale, gait speed and dual-task will be used | One year | No |
Primary | Fear of falling | The Falls Efficacy scale - international will be used | One year | No |
Primary | Muscle strength in upper and lower extremities | A dynamometer will be used | One year | No |
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