Longitudinal Study of Patients Following Long Bone Fracture

NCT01170572 | Completed

• 2 other identifiers: 00707610/H0805/6
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vitamin D; Long Bone Fracture

Outcome Measures

Primary Outcomes (1)

• Serum concentration of 24,25-dihyroxyvitamin D at 5-14 days post cross sectional long bone or clavicle fracture, compared with baseline.

  5-14 days post fracture

Secondary Outcomes (2)

• Serum concentrations of vitamin D metabolites (including 1,25-dihydroxyvitamin D and 25-hydroxyvitamin D) and markers of bone healing

  Baseline, 5-14 days, and 4-10 weeks post fracture

• Peripheral blood expression of genes encoding enzymes in the vitamin D metabolic pathway.

  Baseline, 5-14 days, and 4-10 weeks post fracture

Study Arms (1)

Long bone fracture

Patients presenting to accident and emergency during the study period with long bone or clavicle fracture

Other: No intervention

Interventions

No intervention OTHER

No intervention

Long bone fracture

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Taking medication affecting vitamin D metabolism - carbamazepine, phenobarbital, phenytoin or primidone
• Taking vitamin D supplement \> 800 IU/day
• Abdominal visceral injury, pleural injury (except pneumothorax), spinal cord injury, or GCS \< 15 at presentation to hospital
• Known Paget's disease, osteopetrosis, metastatic bone cancer, or primary bone cancer
• Current prisoners
• Currently taking part in another clinical research project

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• London Deanery: collaborator

Study Sites (1)

The Royal London Hospital

London, London, E1 1BB, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples will be retained

Study Officials

• Adrian Martineau, MRCP

  Queen Mary University of London

  STUDY DIRECTOR

• Tim Harris, BM BS

  Barts and the London NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: July 27, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 7, 2012

Record last verified: 2012-11

Locations

GB (1)