Fractures and Bisphosphonates - the FaB trial

• Research type

  Research Study

• Full title

  Fractures and Bisphosphonates: A double-blind, randomised controlled trial on the effect of alendronic acid on healing and clinical outcomes of wrist fractures

• IRAS ID

  74133

• Contact name

  Stuart Ralston

• Sponsor organisation

  University Of Edinburgh

• Eudract number

  2011-000988-28

• ISRCTN Number

  to be assigned

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study aims to find out if alendronic acid, a drug widely used in post-menopausal women with osteoporosis to prevent bone fractures, has any effect on the healing of wrist fractures.Alendronic acid is from a group of drugs called bisphosphonates. It improves the density of bones by slowing down the rate that calcium is lost.Bisphosphonates, including alendronate, are also known to slow the rate at which bone is renewed and repaired. From that there is a theoretical risk that bisphosphonates could affect the healing time of a bone fracture, as healing involves removal of damaged bone and replacement with new bone. A retrospective review showed that there was not a clinically relevant difference in healing time if they were on a bisphosphonate, but this study was small (196 patients in total, only 43 on bisphosphonates). On the other hand some experimental studies in animals have shown that bisphosphonates like alendronate increase strength of the healing bone at the fracture site, which could be beneficial.If it is found that alendronic acid significantly delays fracture healing, then it may be advisable for clinicians to temporarily withdraw alendronic acid treatment following a fracture, or to delay treatment until the fracture has fully healed.The patient population will be men and women aged 50 or over who have a newly-diagnosed wrist fracture. Patients cannot be on bisphosphonates (or other drugs that affect their bones) and must be able to take alendronic acid.Participants will have to take alendronic acid for 24 weeks and visit hospital for X-rays, assessments and questionnaires 5 times in 6 months. Participants will also have 2 phone calls at home.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  11/AL/0319

• Date of REC Opinion

  3 Aug 2011

• REC opinion

  Further Information Favourable Opinion