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Table 2 Overview of laboratory measurements 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 12–24

Week 24

Week 25–36

Week 37–48

Week 49

Calcium

X*

(X)β

   

X

  

X*

Magnesium

X*

    

X

  

X*

Phosphate

X*

    

X

  

X*

Aluminum

X*

       

X*

Creatinine (and eGFR)

X*

    

X

  

X*

ASAT

X*

    

X

  

X*

ALAT

X*

    

X

  

X*

Albumin

X*

(X)β

   

X

  

X*

CRP

X*

       

X*

Complete blood count

X*

       

X*

ESR

X*

       

X*

Ferritin

X*

       

X*

PTH

X*

       

X*

25-OH-vitamin D

X*

(X)β

   

X

  

X*

Copper

X*

        

Zinc

X*

        

Tuberculosis (Quantiferon)

X*

        

Brucella antibodies

X*

        

HIV 1/2 antibodies p24 antigen

X*

        

Rubella IgG & IgM

X*

        

CMV QDNA

X*

        

Human herpesvirus type 6 QDNA

X*

        

Human herpesvirus type 8 DNA

X*

        
  1. Abbreviations: TC = telephone consultation, eGFR = estimated glomerular filtration rate, ASAT = aspartate transaminase, ALAT = alanine transaminase, CRP = C-reactive protein, ESR = erythrocyte sedimentation rate, PTH = parathyroid hormone, HIV = human immunodeficiency virus, Ig = immunoglobulin, CMV = cytomegalovirus, (Q)DNA = (quantitative)deoxyribonucleic acid
  2. α Each cycle 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