The Impact of Opioids in Fractures - a Case Control Study

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.

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Key information

Conditions

Fractures Fractures, Bone Wounds and Injuries

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

BG University Hospital Bergmannsheil, Ruhr University Bochum

Bochum, 44789, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Reported Opioid medication before hospital admission

Time frame: 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 outcomes

Bone density measures using Quantitative ultrasound (SAHARA)

Time frame: 10 min

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

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Collaborators

Mundipharma Research GmbH & Co KG

Registry information

Official study title

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

Acronym: FROP

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Mar 19, 2014
Registry last updated: Mar 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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