Clinical trial NCT02252679: Study of the Diagnostic Value of Stable Calcium Isotope Profiling in Bone and Calcium Disorders
Official title: Endogenous Calcium Stable Isotope Study (eCaSIS): Evaluation of MC-ICP-MS as a Diagnostic Tool for Metabolic Bone Diseases and Disorders of Calcium Metabolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Diseases
Osteomalacia
Osteoporosis
Keywords: Bone Turnover Markers
Calcium Isotopes
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: GEOMAR-Helmholtz Centre for Ocean Research
First posted: 2014-09-30
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary care clinical convenience sample Healthy volunteers recruited from the communities in Leuven and neighbouring cities Siblings, parents or other relatives of patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: Likelihood ratio (LR) of urinary calcium δ44/40 Ca (‰) values for diagnosing negative skeletal calcium balance
timeFrame: follow-up will vary on clinical basis, with expected averages of 1 year (for osteoporosis) to 3 months (for other conditions)
Secondary outcomes:
measure: Likelihood ratio (LR) of plasma calcium δ44/40 Ca (‰) values for diagnosing negative skeletal calcium balance
timeFrame: follow-up will vary on clinical basis, with expected averages of 1 year (for osteoporosis) to 3 months (for other conditions)
measure: 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
timeFrame: follow-up will vary on clinical basis, with expected averages of 1 year (for osteoporosis) to 3 months (for other conditions)
Other outcomes:
measure: Inter- and intra-assay variability of plasma and urine calcium δ44/40 Ca (‰) values
timeFrame: follow-up will vary on clinical basis, with expected averages of 1 year (for osteoporosis) to 3 months (for other conditions)
measure: calcium δ44/40 Ca (‰) values of human bone samples
timeFrame: before and 1 year after kidney transplantation
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
city: Kiel
country: Germany
facility: GEOMAR-Helmholtz Centre for Ocean Research
Study officials:
affiliation: UZ Leuven
name: Dirk Vanderschueren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khalil R, Antonio L, Laurent MR, David K, Kim NR, Evenepoel P, Eisenhauer A, Heuser A, Cavalier E, Khosla S, Claessens F, Vanderschueren D, Decallonne B. Early effects of androgen deprivation on bone and mineral homeostasis in adult men: a prospective cohort study. Eur J Endocrinol. 2020 Aug;183(2):181-189. doi: 10.1530/EJE-20-0348.