Fractures Clinical Trial
— FROPOfficial title:
Evaluation of Past Medications in Older Patients With Fractures and Patients Hospitalized for a Non-surgical Reason.
Verified date | March 2016 |
Source | Ruhr University of Bochum |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Observational |
In this study, the risk of opioid medications on fractures in older adults is investigated. Patients from the surgical department with fractures and control patients from the internal department of the same hospital are inquired with a standardized questionaire about demographic and clinical risk factors for fractures. Osteoporotic fracture risk is assessed using quantitative ultrasound. An impact of recent opioid medications on fractures is hypothesised.
Status | Completed |
Enrollment | 1000 |
Est. completion date | February 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria for both groups: - age > 60 years - written informed consent Exclusion Criteria for both groups: - malignant Disease within the last 12 month - troubles with memory, dementia or Parkinsons disease - other fractures within the last 6 month Exclusion Criteria for the fracture group: - alcoholised during the fall - fracture older than 14 days |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | BG University Hospital Bergmannsheil, Ruhr University Bochum | Bochum |
Lead Sponsor | Collaborator |
---|---|
Ruhr University of Bochum | Mundipharma Research GmbH & Co KG |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reported Opioid medication before hospital admission | Standardized assessment of opioid medications taken before fracture or hospital admission to evaluate the impact of opioids in fractures. Exact doses, substances and intake habits are inquired. |
interview: 20 min | No |
Secondary | Bone density measures using Quantitative ultrasound (SAHARA) | Evaluation of fracture risk due to reduced bone density is performed using quantitative ultrasound. | 10 min | No |
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