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Effect of Alendronic Acid on Fracture Healing: A Multicenter Randomized Placebo-Controlled Trial.

Authors
  • Duckworth, Andrew D1, 2
  • McQueen, Margaret M2
  • Tuck, Christopher E1
  • Tobias, Jonathan H3
  • Wilkinson, Jeremy Mark4
  • Biant, Leela C5
  • Pulford, Elizabeth Claire6
  • Aldridge, Stephen7
  • Edwards, Claire8
  • Roberts, Chris P9
  • Ramachandran, Manoj10
  • McAndrew, Andrew Richard11
  • Cheng, Kenneth Ck12
  • Johnston, Phillip13
  • Shah, Nasir H14
  • Mathew, Philip15
  • Harvie, John16
  • Hanusch, Birgit C17
  • Harkess, Ronnie1
  • Rodriguez, Aryelly1
  • And 2 more
  • 1 Edinburgh Clinical Trials Unit, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.
  • 2 Edinburgh Orthopaedic Trauma, Royal Infirmary of Edinburgh, Edinburgh, UK.
  • 3 Musculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
  • 4 Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK.
  • 5 Trauma & Orthopaedic Surgery, University of Manchester, Manchester, UK.
  • 6 Oxford University Hospitals National Health Service (NHS) Foundation Trust, Headington, Oxford, UK.
  • 7 The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
  • 8 Norfolk and Norwich University Hospital Foundation Trust, Norwich, UK.
  • 9 Ipswich Hospital NHS Trust, Ipswich, UK.
  • 10 Royal London Hospital, Barts Health NHS Trust, London, UK.
  • 11 Royal Berkshire Hospital Foundation Trust, Reading, UK.
  • 12 NHS Ayrshire & Arran, Ayr, UK.
  • 13 Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
  • 14 Warrington & Halton Hospitals NHS Foundation Trust, Warrington, UK.
  • 15 Queen's Hospital, Romford, UK.
  • 16 Raigmore Hospital, Inverness, UK.
  • 17 South Tees, Hospitals NHS Foundation Trust, Middlesbrough, UK.
  • 18 Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.
  • 19 Centre for Genomic and Experimental Medicine, MRC Institute of Genetics and Molecular Medicine, University of Edinburgh, Edinburgh, UK.
Type
Published Article
Journal
Journal of Bone and Mineral Research
Publisher
Wiley (John Wiley & Sons)
Publication Date
Jun 01, 2019
Volume
34
Issue
6
Pages
1025–1032
Identifiers
DOI: 10.1002/jbmr.3679
PMID: 30845365
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

There is a concern that bisphosphonates may impair fracture healing because of their inhibitory effects on bone turnover. Here we evaluated the effects of early bisphosphonate therapy on fracture healing and functional outcome following a fracture of the distal radius. The fracture and bisphosphonates (FAB) trial was a double-blind, randomized, placebo-controlled trial involving 15 trauma centers in the United Kingdom. We enrolled 421 bisphosphonate-naive patients aged ≥50 years with a radiographically confirmed fracture of the distal radius and randomized them in a 1:1 ratio to receive alendronic acid 70 mg once weekly (n = 215) or placebo (n = 206) within 14 days of the fracture. The primary outcome measure was the proportion of fractures that had radiologically united at 4 weeks as assessed by an observer, blinded to treatment allocation. Secondary outcomes included the Disabilities of the Arm Shoulder and Hand (DASH) questionnaire, range of wrist movement and grip strength, pain and analgesia requirements, and the rate of malunion. The mean ± SD age of participants was 63 ± 8.5 years and 362 (86%) were female. At 4 weeks, 48 of 202 (23.8%) fractures had united in the alendronic acid group compared with 52 of 187 (27.8%) in the placebo group (observed absolute proportion difference 4.0%; 95% CI, -4.7% to 12.8%; p = 0.36). The absolute proportion difference between groups based on imputed data was 4.5% (95% CI, -4.7% to 13.8%; p = 0.30). There was no significant difference in the proportion of fractures that had united at any other time point and no differences in the DASH score, pain at the fracture site, grip strength, or any other clinical outcome. We conclude that among patients aged 50 years and above with a distal radius fracture, early administration of alendronic acid does not adversely affect fracture union or clinical outcome. These findings suggest bisphosphonate therapy can be safely commenced early after fracture if clinically indicated. © 2019 American Society for Bone and Mineral Research. © 2019 American Society for Bone and Mineral Research.

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