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NCT02252679·Not applicable·OBSERVATIONAL

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

TeriparatideOtherCompleted

Status

Completed

Phase

Not applicable

Enrollment

54

Locations

2

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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.

Full 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

Treatment arms and agents.

No intervention details reported.

Timeline

From registration to results.

  1. First posted

    Sep 30, 2014

  2. Study start

    Oct 2014

  3. Primary completion

    Dec 2018

  4. Study completion

    Dec 2018

  5. Results posted

    Not reported

  6. Registry updated

    Nov 6, 2020

Outcomes

What the study measures.

Primary outcomes

Likelihood ratio (LR) of urinary calcium δ44/40 Ca (‰) values for diagnosing negative skeletal calcium balance

Time frame · 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 outcomes

Likelihood ratio (LR) of plasma calcium δ44/40 Ca (‰) values for diagnosing negative skeletal calcium balance

Time frame · 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

Time frame · 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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
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

Study locations

2 registered sites.

Belgium · Germany. Showing up to 24 locations stored in the fast local snapshot.

UZ Leuven

Leuven, Belgium

GEOMAR-Helmholtz Centre for Ocean Research

Kiel, Germany

Publications

Results and literature.

PMID 32454455 ↗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.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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