Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02090972
Other study ID # FROP_BHL_Bochum
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT00137085 - Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation N/A
Completed NCT00152321 - Strategies Targeting Osteoporosis to Prevent Recurrent Fractures N/A
Completed NCT00235404 - Randomized Controlled Trial of Health Care to Elderly Patients. N/A
Completed NCT01127711 - Cohort of Swedish Men N/A
Completed NCT00060970 - Evaluating Muscle Function After Ankle Surgery N/A
Completed NCT02576730 - Functional Outcome Assessment After (Calcaneal) Trauma Surgey N/A
Completed NCT02074969 - Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures N/A
Withdrawn NCT00355420 - Evaluation of the Change in Length of the Leg in Children After Treatment of Femur Fractures. Phase 2
Completed NCT00767780 - The Effect of a New Biomechanical Device N/A
Completed NCT00129142 - Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy Phase 3
Terminated NCT03367169 - Surgery of the Pilon Fractures N/A
Active, not recruiting NCT01452243 - Prevention of Falls and Fractures in Old People by Administration of Calcium and Vitamin D. Randomized Clinical Trial Phase 3
Completed NCT00545350 - Exercise Intervention to Prevent Fall-related Fractures and Other Injuries : The Ossébo Study N/A
Terminated NCT00387686 - A Phase 2/3 Multicenter, Controlled Trial Of rhBMP-2/CPM In Tibial Fractures Phase 2/Phase 3
Completed NCT02292316 - Falls With Fracture : Role of Cognitive Disorders and Comparison With Bone Fragility N/A
Completed NCT01136616 - CT Analysis of Structural Buttresses in the Traumatised Nose Phase 2
Recruiting NCT02237040 - A New Treatment Protocol for Paediatric Mandibular Condylar Fractures N/A
Completed NCT00872105 - Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle N/A
Completed NCT00652548 - Use of Ultrasound to Evaluate Clavicle Fractures in Pediatric Patients N/A
Completed NCT00079521 - Therapeutic Touch for Wrist Fractures in Postmenopausal Women Phase 2