title: Intravenous neridronate in the treatment of acute painful knee osteoarthritis: a randomized controlled study.
abstract: OBJECTIVE
  The aim of this randomized, double-blind, placebo-controlled study was to assess the efficacy of i.v. neridronate in controlling pain in patients with acute painful knee OA.
  
  
  METHODS
  Sixty-four patients with acute knee pain (<3 months duration) suffering from knee OA with an MRI showing bone marrow lesions (BMLs) were randomized to receive either neridronate 100 mg given four times over 10 days or placebo. After 50 days the patients underwent clinical assessment and a further MRI was performed. Primary outcome was pain changes measured by a visual analogue scale (VAS; range 0-100). Secondary endpoints were WOMAC pain score, McGill pain questionnaire and 36-Item Short Form Health Survey. BMLs were evaluated by whole-organ MRI score.
  
  
  RESULTS
  At the day of the last infusion the VAS decreased significantly more in the neridronate group [from 59.0 (s.d. 14.7) to 30.4 (s.d. 15.6); -48.4%; P < 0.001]. Fifty days later the VAS remained unchanged in the placebo group, while a further significant decrease was observed in the neridronate group [from 30.4 (s.d. 15.6) to 9.4 (s.d. 10.8); -69.1%; P < 0.001]. Significant improvements compared with the placebo group were found for most of the other indices of pain and quality of life. The BMLs score in the neridronate group showed significant decreases compared with basal values and those of the placebo-treated patients. Four months after the treatment, 72% of the placebo-treated patients resumed analgesic or anti-inflammatory drugs, but only 12.9% resumed treatment in the neridronate group.
  
  
  CONCLUSIONS
  In patients with acute painful knee OA, four infusions of neridronate are associated with a clinically relevant pain benefit.
  
  
  BACKGROUND
  ClinicalTrials.gov (http://clinicaltrials.gov), NCT01803360.
authors.affiliation: Bone Diseases Unit, Department of Rheumatology, varenna@gpini.it.
authors.forename: Massimo
authors.initials: M
authors.lastname: Varenna
authors.affiliation: Bone Diseases Unit, Department of Rheumatology.
authors.forename: Francesca
authors.initials: F
authors.lastname: Zucchi
authors.affiliation: Department of Radiology.
authors.forename: Simonetta
authors.initials: S
authors.lastname: Failoni
authors.affiliation: Department of Rheumatology and.
authors.forename: Andrea
authors.initials: A
authors.lastname: Becciolini
authors.affiliation: Knee Surgery Unit, Department of Orthopedics, Gaetano Pini Institute, Milan, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Berruto
mesh_terms: D000208:Acute Disease; D000368:Aged; D004164:Diphosphonates / Q000008:administration & dosage* / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000188:drug therapy*; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D004164:Diphosphonates; C053389:6-amino-1-hydroxyhexane-1,1-diphosphonate
keywords: bisphosphonates; knee; neridronate; osteoarthritis; pain