FracturesFROPNCT02090972
The Impact of Opioids in Fractures - a Case Control Study
An observational study of Fractures, run by Ruhr University of Bochum at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Fractures
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2014to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hospitalized patients in University Hospital, surgical and internal department
Who may be able to join
- age > 60 years
- written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
BG University Hospital Bergmannsheil, Ruhr University Bochum
Bochum, 44789
About this study
Official title: Evaluation of Past Medications in Older Patients With Fractures and Patients Hospitalized for a Non-surgical Reason.
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.
- Conditions
- Fractures
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: interview: 20 min
Secondary outcomes (1)
Bone density measures using Quantitative ultrasound (SAHARA)
Evaluation of fracture risk due to reduced bone density is performed using quantitative ultrasound.
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Collaborators
- Mundipharma Research GmbH & Co KG
- Responsible party
- Principal investigator, Christoph Maier, Prof. Dr., Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090972
- Sponsor's protocol ID
- FROP_BHL_Bochum
- Acronym
- FROP
- Status last verified
- Mar 2016
- First submitted
- 17 Mar 2014
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Past Medications in Older Patients With Fractures and Patients Hospitalized for a Non-surgical Reason.
- ClinicalTrials.gov ID
- NCT02090972
- Acronym / sponsor ID
- FROP / FROP_BHL_Bochum
- Conditions
- Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Collaborators
- Mundipharma Research GmbH & Co KG
- Study start
- Mar 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 19 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospitalized patients in University Hospital, surgical and internal department
Key inclusion criteria (2 listed)
- age > 60 years
- written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Bone density measures using Quantitative ultrasound (SAHARA)
Time frame: 10 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fractures, run by Ruhr University of Bochum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reported Opioid medication before hospital admission (time frame: interview: 20 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2016.