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

Osteoporosis Clinical Trial

— eCaSIS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02252679
• Other study ID #: UZ Leuven - s56719
• Status: Completed
• Start date: October 2014
• Est. completion date: December 2018

Study information

• Verified date: October 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases
• Osteomalacia
• Osteoporosis

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven
Germany	GEOMAR-Helmholtz Centre for Ocean Research	Kiel

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	GEOMAR-Helmholtz Centre for Ocean Research

Countries where clinical trial is conducted

Belgium,  Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Inter- and intra-assay variability of plasma and urine calcium d44/40 Ca (‰) values		follow-up will vary on clinical basis, with expected averages of 1 year (for osteoporosis) to 3 months (for other conditions)
Other	calcium d44/40 Ca (‰) values of human bone samples	Secondary use of bone biopsy samples obtained in the Leuven Bone Biopsy Program (NCT01886950)	before and 1 year after kidney transplantation
Primary	Likelihood ratio (LR) of urinary calcium d44/40 Ca (‰) values for diagnosing negative skeletal calcium balance	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.	follow-up will vary on clinical basis, with expected averages of 1 year (for osteoporosis) to 3 months (for other conditions)
Secondary	Likelihood ratio (LR) of plasma calcium d44/40 Ca (‰) values for diagnosing negative skeletal calcium balance	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.	follow-up will vary on clinical basis, with expected averages of 1 year (for osteoporosis) to 3 months (for other conditions)
Secondary	Area under the receiver-operator curve (AUROC) of calcium d44/40 Ca (‰) values compared to bone turnover markers, with expert clinical diagnosis as the golden standard	Osteocalcin and bèta-CTx (C-terminal telopeptide of type I collagen) will be measured.	follow-up will vary on clinical basis, with expected averages of 1 year (for osteoporosis) to 3 months (for other conditions)