title: Clinical efficacy of oral alendronate in ankylosing spondylitis: a randomised placebo-controlled trial.
abstract: OBJECTIVE
  A prospective, double blind, randomised, placebo controlled trial over 2 years was performed to test the efficacy of alendronate, an oral aminobisphosphonate, in improving symptoms and arrest disease progression in patients with mild to severe ankylosing spondylitis (AS).
  
  
  METHODS
  180 patients with AS were randomised to receive weekly alendronate 70 mg or placebo (1:1 randomisation). BAS-G was the primary outcome measure with Bath indices as secondary outcomes. Vertebral x-rays were performed at 0 and 24 months. Biomarkers (including CRP, IL-1beta, IL6, VEGF, MMP-1, and MMP-3) were collected during the first 12 months.
  
  
  RESULTS
  There was no significant difference between the placebo and treatment groups in any of the recorded outcomes over the 2 years including clinical indices, biomarkers, and radiology. The change in BAS-G, the primary outcome measure, was -0.21 for the treatment group and -0.42 for the placebo group p=0.57. Change in all other clinical outcome measures were also non-significant; BASDAI p=0.86, BASFI p=0.37, BASMI p=0.021. Sub-group analysis of those subjects with a baseline BASDAI >4 were also non-significant.
  
  
  CONCLUSIONS
  This prospective study demonstrates that alendronate 70mg weekly for 2 years was no more efficacious than placebo in improving clinical or laboratory measures of disease activity or measures of physical impact in subjects with mild to severe active AS.
  
  
  BACKGROUND
  ID SRCTN12308164, registered on 15.12.2015.
authors.affiliation: Department of Rheumatology, Tameside Hospital, Ashton-Under-Lyne, Lancashire, UK.
authors.forename: Lucy
authors.initials: L
authors.lastname: Coates
authors.affiliation: Haywood Rheumatology Centre, Stoke on Trent, UK.
authors.forename: Jonathan C
authors.initials: JC
authors.lastname: Packham
authors.affiliation: Department of Rheumatology, Southmead Hospital, Bristol, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Creamer
authors.affiliation: Fife Rheumatic Diseases Unit, Whyteman's Brae Hospital, Kirkcaldy, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Hailwood
authors.affiliation: Rheumatology, Royal National Hospital for Rheumatic Diseases, Bath, UK.
authors.forename: Ashley S
authors.initials: AS
authors.lastname: Bhalla
authors.affiliation: Department of Rheumatology, Royal free Hospital NHS Foundation Trust, London, UK.
authors.forename: Kuntal
authors.initials: K
authors.lastname: Chakravarty
authors.affiliation: Department of Rheumatology, The Royal Wolverhampton NHS Trust, Cannock Chase Hospital, Cannock, UK.
authors.forename: Diamuid
authors.initials: D
authors.lastname: Mulherin
authors.affiliation: Rheumatology, Royal National Hospital for Rheumatic Diseases, Bath, UK.
authors.forename: Gordon
authors.initials: G
authors.lastname: Taylor
authors.affiliation: Institute for Science and Technology in Medicine, Keele University, Keele, UK.
authors.forename: Derek L
authors.initials: DL
authors.lastname: Mattey
authors.affiliation: Rheumatology, Royal National Hospital for Rheumatic Diseases, Bath, UK. ashok.bhalla@nhs.net.
authors.forename: Ashok K
authors.initials: AK
authors.lastname: Bhalla
mesh_terms: D000284:Administration, Oral; D000328:Adult; D019386:Alendronate / Q000008:administration & dosage* / Q000009:adverse effects; D015415:Biomarkers / Q000097:blood; D050071:Bone Density Conservation Agents / Q000008:administration & dosage* / Q000009:adverse effects; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012720:Severity of Illness Index; D013167:Spondylitis, Ankylosing / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D015415:Biomarkers; D050071:Bone Density Conservation Agents; D019386:Alendronate