NCT02090972

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

11 months

First QC Date

March 17, 2014

Last Update Submit

March 30, 2016

Conditions

Fractures

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Bone density measures using Quantitative ultrasound (SAHARA)

    10 min

Study Arms (2)

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

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hospitalized patients in University Hospital, surgical and internal department

You may qualify if:

  • age \> 60 years
  • written informed consent

You may not qualify if:

  • malignant Disease within the last 12 month
  • troubles with memory, dementia or Parkinsons disease
  • other fractures within the last 6 month
  • alcoholised during the fall
  • fracture older than 14 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BG University Hospital Bergmannsheil, Ruhr University Bochum

Bochum, 44789, Germany

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof., Dr.

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 19, 2014

Study Start

March 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 31, 2016

Record last verified: 2016-03

Locations

DE(1)