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Table 1 Schedule of assessments

From: A protocol for a multicentre, randomised, double-blind, placebo-controlled trial to compare the effect of annual infusions of zoledronic acid to placebo on knee structural change and knee pain over 24 months in knee osteoarthritis patients – ZAP2

 

Screening

Baseline (Month 0)

Day 3 Post-Infusion

Month 3

Month 6

Month 12

Day 3 Post-Infusion

Month 18

Month 24

Informed consent

x

        

Clinical examination

x

        

Knee x-ray

x

        

Bloods

x

   

x*

    

Knee MRI

x

   

x

   

x

Randomisation

 

x

       

Clinic measures

 Leg strength

 

x

  

x

x

  

x

 Height and weight

 

x

  

x

   

x

 First void fasting urine

 

x*

  

x*

    

 Infusion

 

x

   

x

   

Questionnaire measures

 Demographics (sex, date of birth)

x

        

 Knee VAS

x

x

 

x

x

x

 

x

x

 Knee WOMAC

 

x

 

x

x

x

 

x

x

 Medication use

x

  

x

x

x

 

x

x

 Knee surgery

x

  

x

x

x

 

x

x

 Knee joint injection

    

x

x

 

x

x

 Safety (adverse events)

 

x

x

x

x

x

x

x

x

 Acute phase reactions

  

x

   

x

  

 Hand VAS

 

x

 

x

x

x

 

x

x

 Back VAS

 

x

 

x

x

x

 

x

x

 AQoL-4D

 

x

  

x

   

x

 Overall change in pain and function

        

x

 Treatment guessing

        

x

  1. *Only being performed at the Hobart, Melbourne and Sydney study sites
  2. MRI magnetic resonance imaging, VAS visual analogue scale, WOMAC Western Ontario and McMasters Universities Osteoarthritis Index, AQoL-4D The Assessment of Quality of Life