Patients with knee pain, knee osteoarthritis and bone marrow lesions, randomised to zoledronic acid or placebo, assessed by knee cartilage volume loss over 24 months, knee pain at 3, 6, 12, 18, and 24 months, and bone marrow lesion size over 6 and 24 months

Menzies Research Institute Tasmania, University of Tasmania0 sites264 target enrollmentJanuary 14, 2013

Overview

No summary available.

Registry

who.int

Start Date

January 14, 2013

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Menzies Research Institute Tasmania, University of Tasmania

•1\) Males and females with significant knee pain on most days (defined as a pain score \>\= 40 mm on a 100\-mm visual analogue scale (VAS)).
•2\) Aged \>\= 50 years old.
•3\) Bone marrow lesions present on MRI.
•4\) Meeting the American College of Rheumatology (ACR) criteria for symptomatic knee osteoarthritis.

•1\)Prior use of bisphosphonates, except according to the washout schedule:
•2 years (if use \>48 weeks)
•1 year (if used \>8 weeks but \<48 weeks)
•6 months (if used \>2 weeks but \<8 weeks)
•2 months (if used \<2 weeks)
•Any IV bisphosphonate within the prior 2 years
•2\)History of non\-traumatic iritis or uveitis
•3\)Abnormal blood tests \[serum calcium \>2\.75 mmol/L (11\.0 mg/dL) or \<2\.00 mmol/L (8\.0 mg/dL) or creatinine clearance \< 35 ml/min]
•4\)Serum 25\-hydroxyvitamin D concentrations \<40 nmol/L
•5\)Use of any investigational drug(s) and/or devices within 30 days or 5 half\-lives (whichever is longer) of the drug prior to randomisation