Longitudinal Study of Patients Following Long Bone Fracture

Completed

• Conditions: Long Bone Fracture; Vitamin D
• Interventions: Other: No intervention

• Registration Number: NCT01170572
• Lead Sponsor: Barts & The London NHS Trust

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-07-26
• Study First Submitted QC: 2010-07-26
• Study First Posted: 2010-07-27
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-06
• Last Update Posted: 2012-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Long bone fracture	No intervention	Patients presenting to accident and emergency during the study period with long bone or clavicle fracture

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Peripheral blood expression of genes encoding enzymes in the vitamin D metabolic pathway.	Baseline, 5-14 days, and 4-10 weeks post fracture
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

Trial Locations

Locations (1)

The Royal London Hospital; 🇬🇧 London, United Kingdom