Longitudinal Study of Patients Following Long Bone Fracture

Barts & The London NHS Trust

Status: Completed

Conditions: Vitamin D; Long Bone Fracture

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT01170572

10/H0805/6 (Other Identifier)

007076

Details and patient eligibility

About

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

Enrollment: 33 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

33 participants in 1 patient group

Long bone fracture

Description:

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

Treatment:

Other: No intervention