MedDataX Logo

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

NCT ID: NCT02252679

Last Updated: 2020-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bone Diseases Osteomalacia Osteoporosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Bone Turnover Markers Calcium Isotopes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Osteoporosis

Postmenopausal women, men \> age 50 years, or other patients with well-established causes of secondary osteoporosis (incl. glucocorticoid-induced osteoporosis, transplantation-related osteoporosis, disuse osteoporosis, etc.) N=20 treated with antiresorptive drugs N=10 treated with osteoanabolic drugs (e.g. teriparatide, Forsteo)

No interventions assigned to this group

Calcium malabsorption

N=10 Patients with clinically obvious potential causes of calcium malabsorption (incl. severe vitamin D-deficiency, Scopinaro or other bariatric surgery, exocrine pancreatic insufficiency/steatorrhea, cystic fibrosis, inflammatory bowel disease, celiac disease, anorexia nervosa/eating disorders, malnutrition, etc.), with or without bone pains, muscle weakness and other typical osteomalacia symptoms. Confirmed by 24h urine collection showing calciuria \<100 mg/24h.

No interventions assigned to this group

Various disorders

Exploratory, heterogeneous group of calcium-related disorders (incl.hypercalcemia, hypocalcemia, primary/secondary/tertiary hyperparathyroidism, hypoparathyroidism, vitamin D deficiency, X-linked/autosomal dominant hypophosphatemic rickets, familial hypocalciuric hypocalcemia,etc.) N=20

No interventions assigned to this group

Normal control subjects

N=40 Men and women ≤ 40 years recruited from the population

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GEOMAR-Helmholtz Centre for Ocean Research

UNKNOWN

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dirk Vanderschueren, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UZ Leuven

Leuven, , Belgium

Site Status

GEOMAR-Helmholtz Centre for Ocean Research

Kiel, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 32454455 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UZ Leuven - s56719

Identifier Type: -

Identifier Source: org_study_id