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Longitudinal Study of Patients Following Long Bone Fracture

This study is currently recruiting participants.
Verified February 2011 by Barts & The London NHS Trust
Sponsor:
Collaborator:
London Deanery
Information provided by:
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT01170572
First received: July 26, 2010
Last updated: February 22, 2011
Last verified: February 2011
History of Changes
  Purpose

Studies in chickens show that blood levels of a particular form of vitamin D (called 24,25-dihydroxvitamin D) increase after bone fracture. Laboratory studies show that this form of vitamin D helps the bone healing process in chickens. The investigators want to find out whether blood levels of this form of vitamin D increase after bone fracture in humans. Previous research studies have not addressed this question. The results of this research could eventually lead to the development of new treatments to help bone healing after fracture.

Patients will be asked to take part in this study if they are aged 16 years or older and come to the Royal London Hospital with a broken bone in the arm or leg or collar bone (clavicle). They will be asked to give a 20ml (about 4 teaspoons) blood sample on three occasions: at the start of the study, at 5-14 days after the fracture; and at 4-10 weeks after the fracture. The rest of their normal care would not be affected. Follow-up blood samples will be timed to coincide with routine clinic visits which are scheduled as part of normal clinical care. Patients' vitamin D level will be measured as part of the study, and those who have a low vitamin D level will be informed about this, and advised about appropriate vitamin D supplementation. The investigators will let the patient or their GP know if any blood tests are abnormal


Condition Intervention
Vitamin D
Long Bone Fracture
 Other: No intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Study of Vitamin D Metabolism and Bone Healing in Adult Patients With Recent Long Bone Fracture

Resource links provided by NLM:

MedlinePlus related topics: Fractures Vitamin D
U.S. FDA Resources

Further study details as provided by Barts & The London NHS Trust:

Primary Outcome Measures:
  • Serum concentration of 24,25-dihyroxyvitamin D at 5-14 days post cross sectional long bone or clavicle fracture, compared with baseline. [ Time Frame: 5-14 days post fracture ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum concentrations of vitamin D metabolites (including 1,25-dihydroxyvitamin D and 25-hydroxyvitamin D) and markers of bone healing [ Time Frame: Baseline, 5-14 days, and 4-10 weeks post fracture ] [ Designated as safety issue: No ]
  • Peripheral blood expression of genes encoding enzymes in the vitamin D metabolic pathway. [ Time Frame: Baseline, 5-14 days, and 4-10 weeks post fracture ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood samples will be retained


Estimated Enrollment: 100
Study Start Date: March 2010
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Long bone fracture
Patients presenting to accident and emergency during the study period with long bone or clavicle fracture
 Other: No intervention
No intervention

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients presenting to the Accident and Emergency Department, Royal London Hospital, Whitechapel with a long bone or clavicle fracture

Criteria

Inclusion Criteria:

  1. Any cross-shaft long bone or clavicle fracture within last 12 hours
  2. Able to give written informed consent
  3. Age ≥ 16 years
  4. Fused physes (physiologically adult)

Exclusion Criteria:

  1. Taking medication affecting vitamin D metabolism - carbamazepine, phenobarbital, phenytoin or primidone
  2. Taking vitamin D supplement > 800 IU/day
  3. Abdominal visceral injury, pleural injury (except pneumothorax), spinal cord injury, or GCS < 15 at presentation to hospital
  4. Known Paget's disease, osteopetrosis, metastatic bone cancer, or primary bone cancer
  5. Current prisoners
  6. Currently taking part in another clinical research project
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170572

Contacts
Contact: Adam D Briggs, MA BM BCh 07765073857 adambriggs@doctors.org.uk

Locations
United Kingdom
The Royal London Hospital Recruiting
London, United Kingdom, E1 1BB
Contact: Tim Harris, BM BS     02073777000     tim.harris@bartsandthelondon.nhs.uk    
Principal Investigator: Tim Harris, BMBS            
Sub-Investigator: Adam Briggs, BM BCh            
Sub-Investigator: Anisa Nasir, BM BS            
Sub-Investigator: Robert Hughes, BM BCh            
Sponsors and Collaborators
Barts & The London NHS Trust
London Deanery
Investigators
Study Director: Adrian Martineau, MRCP Queen Mary University of London
Principal Investigator: Tim Harris, BM BS Barts and the London NHS Trust
  More Information

No publications provided

Responsible Party: Dr Tim Harris, Barts and the London NHS Trust
ClinicalTrials.gov Identifier: NCT01170572     History of Changes
Other Study ID Numbers: 007076, 10/H0805/6
Study First Received: July 26, 2010
Last Updated: February 22, 2011
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on October 17, 2012