Clinical trial NCT01170572: Longitudinal Study of Patients Following Long Bone Fracture
Official title: Longitudinal Study of Vitamin D Metabolism and Bone Healing in Adult Patients With Recent Long Bone Fracture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D
Long Bone Fracture
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
Collaborators: name: London Deanery
First posted: 2010-07-27
Enrollment: 33
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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


Eligibility 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

Primary outcomes:
measure: Serum concentration of 24,25-dihyroxyvitamin D at 5-14 days post cross sectional long bone or clavicle fracture, compared with baseline.
timeFrame: 5-14 days post fracture
Secondary outcomes:
measure: Serum concentrations of vitamin D metabolites (including 1,25-dihydroxyvitamin D and 25-hydroxyvitamin D) and markers of bone healing
timeFrame: Baseline, 5-14 days, and 4-10 weeks post fracture
measure: Peripheral blood expression of genes encoding enzymes in the vitamin D metabolic pathway.
timeFrame: Baseline, 5-14 days, and 4-10 weeks post fracture
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The Royal London Hospital
Study officials:
affiliation: Queen Mary University of London
name: Adrian Martineau, MRCP
role: STUDY_DIRECTOR
affiliation: Barts and the London NHS Trust
name: Tim Harris, BM BS
role: PRINCIPAL_INVESTIGATOR
References: