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FROP: The Impact of Opioids in Fractures - a Case Control Study

Sponsor
Ruhr University of Bochum (Other)
Overall Status
Completed
CT.gov ID
NCT02090972
Collaborator
Mundipharma Research GmbH & Co KG (Industry)
1,000
Enrollment
1
Location
11.1
Duration (Months)
90.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1000 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Past Medications in Older Patients With Fractures and Patients Hospitalized for a Non-surgical Reason.
    Study Start Date :
    Mar 1, 2014
    Actual Primary Completion Date :
    Feb 1, 2015
    Actual Study Completion Date :
    Feb 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with fracture

    fracture within the last 14 days no other fractures within the last 6 month patients >60 years
    Control Patients

    patients hospitalized for an internal reason no other fractures within the last 6 month patients >60 years

    Outcome Measures

    Primary Outcome Measures

    1. Reported Opioid medication before hospital admission [interview: 20 min]

      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.

    Secondary Outcome Measures

    1. Bone density measures using Quantitative ultrasound (SAHARA) [10 min]

      Evaluation of fracture risk due to reduced bone density is performed using quantitative ultrasound.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 BG University Hospital Bergmannsheil, Ruhr University Bochum Bochum Germany 44789

    Sponsors and Collaborators

    • Ruhr University of Bochum
    • Mundipharma Research GmbH & Co KG

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Christoph Maier, Prof. Dr., Prof., Dr., Ruhr University of Bochum
    ClinicalTrials.gov Identifier:
    NCT02090972
    Other Study ID Numbers:
    • FROP_BHL_Bochum
    First Posted:
    Mar 19, 2014
    Last Update Posted:
    Mar 31, 2016
    Last Verified:
    Mar 1, 2016
    Additional relevant MeSH terms:
    Fractures, Bone

    Study Results

    No Results Posted as of Mar 31, 2016