The Impact of Opioids in Fractures - a Case Control Study

Fractures Clinical Trial

— FROP  

Official title:

Evaluation of Past Medications in Older Patients With Fractures and Patients Hospitalized for a Non-surgical Reason.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02090972
• Other study ID #: FROP_BHL_Bochum
• Status: Completed
• Phase: N/A
• First received: March 17, 2014
• Last updated: March 30, 2016
• Start date: March 2014
• Est. completion date: February 2015

Study information

• Verified date: March 2016
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fractures
• Fractures, Bone

Locations

Country	Name	City	State
Germany	BG University Hospital Bergmannsheil, Ruhr University Bochum	Bochum

Sponsors (2)

Lead Sponsor	Collaborator
Ruhr University of Bochum	Mundipharma Research GmbH & Co KG

Country where clinical trial is conducted

Germany, 

Outcome

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