Longitudinal Study of Patients Following Long Bone Fracture

Longitudinal Study of Vitamin D Metabolism and Bone Healing in Adult Patients With Recent Long Bone Fracture

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

Study Overview

• Status: Completed
• Conditions: Long Bone Fracture; Vitamin D
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, E1 1BB
    • The Royal London Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Long bone fracture; Patients presenting to accident and emergency during the study period with long bone or clavicle fracture	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Barts & The London NHS Trust
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: July 26, 2010
• First Submitted That Met QC Criteria: July 26, 2010
• First Posted (Estimate): July 27, 2010

Study Record Updates

• Last Update Posted (Estimate): November 7, 2012
• Last Update Submitted That Met QC Criteria: November 6, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 007076; 10/H0805/6 (Other Identifier: REC number)