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Table 1 Overview of data collection during study period

From: The effects of etidronate on brain calcifications in Fahr’s disease or syndrome: rationale and design of the randomised, placebo-controlled, double-blind CALCIFADE trial

 

Screening

Treatment period

 
 

Visit 1

Visit 2

Cycle 1α

TC 1

Cycle 2α

TC 2

Cycle 3α

Cycle 4α

Completion visit

Weeks of study drug exposure

N/A

N/A

Week 0–12

Week 12

Week 13–24

Week 24

Week 25–36

Week 37–48

Week 49

Informed consent

X

        

Medical history

X*

        

Medication review

X*

        

Physical examination

X*

       

X*

Laboratory measurements

X*

(X)β

   

X

  

X*

CT-scan brain

X*

       

X*

Neuropsychiatric assessment

X*

       

X*

Cognitive assessment

X*

       

X*

Mobility assessment

X*

       

X*

ADL assessment

X*

       

X*

Quality of Life assessment

X*

       

X*

Randomisation

 

X

       

Administer study drug

  

X

 

X

 

X

X

 

Adverse event monitoring

X

X

X

X

X

X

X

X

X

  1. Abbreviations: TC = telephone consultation, ADL = activities of daily living
  2. α Each cyclus starts with etidronate 20 mg/kg for two weeks on and ten weeks off or placebo for two weeks on and ten weeks off
  3. β After correction of a hypocalcaemia or vitamin D deficiency, a participant might be eligible for inclusion again
  4. * Activities marked with an asterisk are considered part of standard of care
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Orphanet Journal of Rare Diseases

ISSN: 1750-1172