Study of the Diagnostic Value of Stable Calcium Isotope Profiling in Bone and Calcium Disorders

Endogenous Calcium Stable Isotope Study (eCaSIS): Evaluation of MC-ICP-MS as a Diagnostic Tool for Metabolic Bone Diseases and Disorders of Calcium Metabolism

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02252679

Acronym

eCaSIS

Enrollment

Registered

2014-09-30

Start date

2014-10-31

Completion date

2018-12-31

Last updated

2020-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Diseases, Osteomalacia, Osteoporosis

Keywords

Bone Turnover Markers, Calcium Isotopes

Brief summary

The purpose of this study is to determine whether mass spectrometry analysis of stable (non-radioactive) calcium isotopes in plasma or urine samples can help in the diagnosis of bone and calcium disorders.

Detailed description

The aim of this pilot study is to explore the diagnostic value of MC-ICP-MS (multicollector inductively coupled plasma mass spectrometry) or TIMS (thermal ionization mass spectrometry) measurement of endogenous stable calcium isotopes in plasma and urine samples in patients seen during routine clinical care at the outpatient clinics (incl. Center for Metabolic Bone Diseases) of the University Hospitals Leuven.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* DXA (dual energy X-ray absorptiometry) T-score known clinically to be = or \< -2.5 OR presence of low-energy osteoporotic fractures (i.e. excluding those of the skull, fingers and toes) \[for osteoporosis and calcium malabsorption patients\]

Exclusion criteria

* inability to provide written informed consent

Design outcomes

Primary

Measure	Time frame	Description
Likelihood ratio (LR) of urinary calcium δ44/40 Ca (‰) values for diagnosing negative skeletal calcium balance	follow-up will vary on clinical basis, with expected averages of 1 year (for osteoporosis) to 3 months (for other conditions)	The sensitivity, specificity, positive and negative predictive value of the new test will be compared to expert clinical diagnosis as the gold standard. This diagnosis is established during follow-up and based on clinical observations, bone mineral density results/changes, bone turnover markers and response to treatments.

Secondary

Measure	Time frame	Description
Likelihood ratio (LR) of plasma calcium δ44/40 Ca (‰) values for diagnosing negative skeletal calcium balance	follow-up will vary on clinical basis, with expected averages of 1 year (for osteoporosis) to 3 months (for other conditions)	The sensitivity, specificity, positive and negative predictive value of the new test will be compared to expert clinical diagnosis as the gold standard. This diagnosis is established during follow-up and based on clinical observations, BMD results, bone turnover markers and response to treatments.
Area under the receiver-operator curve (AUROC) of calcium δ44/40 Ca (‰) values compared to bone turnover markers, with expert clinical diagnosis as the golden standard	follow-up will vary on clinical basis, with expected averages of 1 year (for osteoporosis) to 3 months (for other conditions)	Osteocalcin and bèta-CTx (C-terminal telopeptide of type I collagen) will be measured.

Other

Measure	Time frame	Description
Inter- and intra-assay variability of plasma and urine calcium δ44/40 Ca (‰) values	follow-up will vary on clinical basis, with expected averages of 1 year (for osteoporosis) to 3 months (for other conditions)	—
calcium δ44/40 Ca (‰) values of human bone samples	before and 1 year after kidney transplantation	Secondary use of bone biopsy samples obtained in the Leuven Bone Biopsy Program (NCT01886950)

Countries

Belgium, Germany

Outcome results