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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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London, Verenigd Koninkrijk, E1 1BB
- The Royal London Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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Long bone fracture
Patients presenting to accident and emergency during the study period with long bone or clavicle fracture
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Geen tussenkomst
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Serum concentration of 24,25-dihyroxyvitamin D at 5-14 days post cross sectional long bone or clavicle fracture, compared with baseline.
Tijdsspanne: 5-14 days post fracture
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5-14 days post fracture
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Serum concentrations of vitamin D metabolites (including 1,25-dihydroxyvitamin D and 25-hydroxyvitamin D) and markers of bone healing
Tijdsspanne: Baseline, 5-14 days, and 4-10 weeks post fracture
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Baseline, 5-14 days, and 4-10 weeks post fracture
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Peripheral blood expression of genes encoding enzymes in the vitamin D metabolic pathway.
Tijdsspanne: Baseline, 5-14 days, and 4-10 weeks post fracture
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Baseline, 5-14 days, and 4-10 weeks post fracture
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie directeur: Adrian Martineau, MRCP, Queen Mary University of London
- Hoofdonderzoeker: Tim Harris, BM BS, Barts and the London NHS Trust
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 007076
- 10/H0805/6 (Andere identificatie: REC number)
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