Skip to main content
OpenTrials
Completed

NCT Number: NCT01170572

Longitudinal Study of Patients Following 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

Completed

Looking for future studies?

Notify Me

Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Royal London Hospital

London, E1 1BB, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Collaborators

  • London Deanery

Registry information

Official study title

Longitudinal Study of Vitamin D Metabolism and Bone Healing in Adult Patients With Recent Long Bone Fracture

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 27, 2010
Registry last updated
Nov 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.