Clinical trial NCT01600547: Odense Fallers and Osteoporosis Study
Official title: Odense Fallers and Osteoporosis Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Accidental Falls
Osteoporosis
Disability
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2012-05-17
Enrollment: 322
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients attending the Odense University hospital falls clinic will be recruited to the study Two control groups will be recruited. A questionnaire will be sent to randomly selected community aged matched female controls.

Brief summary: 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.

Detailed description: Study Objectives

1. 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.
2. To evaluate the usefulness of peripheral bone scanning techniques in a falls clinic population.
3. 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
4. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Bone mineral density using DXA of hip and spine regions (Hologic machine)
timeFrame: baseline
measure: Prevalence of vertebral fractures using instant vertebral assessment mode (IVA) of the DXA machine (Hologic machine)
timeFrame: baseline
measure: Bone mineral density of the phalanges using radiographic absorptiometry (Alara Metriscan machine)
timeFrame: baseline
measure: Broad band ultrasound attenuation of the heel using the heel ultrasound machine (Lunar Achilles machine)
timeFrame: baseline
measure: Fall incidences
timeFrame: one year
measure: Mental health state
timeFrame: one year
measure: Health related quality of life
timeFrame: one year
measure: Perceived need
timeFrame: one year
measure: Basis mobility
timeFrame: One year
measure: Fear of falling
timeFrame: One year
measure: Muscle strength in upper and lower extremities
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Odense University Hospital Geriatric department
Study officials:
affiliation: University of Southern Denmark
name: Katja Thomsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense University Hospital
name: Lisbeth Rosenbek Minet, ph.d.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomsen K, Ryg J, Matzen L, Hermann AP, Masud T. Choice of osteoporosis guideline has important implications for the treatment decision in elderly women referred to a fall clinic. Dan Med J. 2014 Dec;61(12):A4980.