Effect of different medications on bone calcium content (CAL-BAL)
Research type
Research Study
Full title
The effect of calcium-based and calcium-free phosphate-binders on bone mineral content, measured by a novel technique of dual-tracer stable calcium isotope method, in children with chronic kidney disease or on dialysis – a time series trial (CAL-BAL)
IRAS ID
268427
Contact name
Rukshana Shroff
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
18BA29, Great Ormond Street Hospital for Children (GOSH) Research and Development reference #
Duration of Study in the UK
1 years, 11 months, 2 days
Research summary
The growing bones of children need calcium in order to mineralise (become strong). Children with kidney failure (called chronic kidney disease; CKD) or on dialysis can often be calcium deficient. They are given medications with extra calcium to help their bones mineralise. However, there is currently no practical way of measuring bone mineralisation; doctors may perform special x-rays, but it takes many months before any bone structure problems become apparent on X-rays. Doctors giving children additional calcium don’t know how much to give. Sometimes children are given too little and their bones don’t mineralise adequately, or they are given too much, and the excess calcium is deposited in their arteries causing cardiac problems. Timely and practical ways of measuring bone mineralisation are needed so doctors can accurately prescribe the amount of calcium containing medicines they give.
The CAL-BAL trial will evaluate a novel potential biomarker of bone mineralisation: the calcium isotope ratio (δ44/42Ca) which will be measured from blood and urine. The trial will collect information on δ44/42Ca for patients with CKD or on dialysis for 28 weeks. It will measure how δ44/42Ca changes when a patient switches from a medicine containing calcium to one not containing calcium. It will also evaluate the association between δ44/42Ca and specialised x-rays of bone and established biomarkers of bone formation and repair.
The data collected in CALBAL will not by itself allow doctors to decide whether δ44/42Ca is good biomarker of bone mineralisation. However, it will provide additional biological and clinical information that will either increase confidence that it is a worthwhile biomarker for further research or exclude it as a useful biomarker. Together with information from previous studies done by the chief investigator which measured the typical δ44/42Ca of healthy children and children with CKD and on dialysis, the data collected in CALBAL may inform the design of a future long-term randomised trial of standard-of-care compared to an approach where δ44/42Ca results are used to prescribe the amount of medicine containing calcium children with CKD or on dialysis are given.REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
19/LO/1421
Date of REC Opinion
23 Sep 2019
REC opinion
Favourable Opinion