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Longitudinal Study of Patients Following Long Bone Fracture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01170572
Recruitment Status : Completed
First Posted : July 27, 2010
Last Update Posted : November 7, 2012
London Deanery
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Vitamin D Long Bone Fracture Other: No intervention

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Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Study of Vitamin D Metabolism and Bone Healing in Adult Patients With Recent Long Bone Fracture
Study Start Date : March 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures Vitamin D

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

Primary Outcome Measures :
  1. Serum concentration of 24,25-dihyroxyvitamin D at 5-14 days post cross sectional long bone or clavicle fracture, compared with baseline. [ Time Frame: 5-14 days post fracture ]

Secondary Outcome Measures :
  1. Serum concentrations of vitamin D metabolites (including 1,25-dihydroxyvitamin D and 25-hydroxyvitamin D) and markers of bone healing [ Time Frame: Baseline, 5-14 days, and 4-10 weeks post fracture ]
  2. Peripheral blood expression of genes encoding enzymes in the vitamin D metabolic pathway. [ Time Frame: Baseline, 5-14 days, and 4-10 weeks post fracture ]

Biospecimen Retention:   Samples With DNA
Whole blood samples will be retained

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01170572

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United Kingdom
The Royal London Hospital
London, United Kingdom, E1 1BB
Sponsors and Collaborators
Barts & The London NHS Trust
London Deanery
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Study Director: Adrian Martineau, MRCP Queen Mary University of London
Principal Investigator: Tim Harris, BM BS Barts and the London NHS Trust
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Responsible Party: Barts & The London NHS Trust Identifier: NCT01170572    
Other Study ID Numbers: 007076
10/H0805/6 ( Other Identifier: REC number )
First Posted: July 27, 2010    Key Record Dates
Last Update Posted: November 7, 2012
Last Verified: November 2012
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries