Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02252679
Other study ID # UZ Leuven - s56719
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06287502 - Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis N/A
Completed NCT03822078 - Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women Phase 1
Recruiting NCT05845021 - Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty N/A
Completed NCT00092066 - A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227) Phase 3
Recruiting NCT04754711 - Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition N/A
Completed NCT04736693 - Replication of the HORIZON Pivotal Fracture Trial in Healthcare Claims Data
Not yet recruiting NCT06431867 - Primary Care Management of Osteoporosis in Older Women
Completed NCT02922478 - Role of Comorbidities in Chronic Heart Failure Study
Recruiting NCT02635022 - Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study
Recruiting NCT02616627 - Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients
Active, not recruiting NCT02617303 - Prevention of Falls and Its Consequences in Elderly People N/A
Completed NCT02566655 - Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis Phase 1
Completed NCT02559648 - Denosumab vs Placebo in Patients With Thalassemia Major and Osteoporosis Phase 2
Not yet recruiting NCT02223572 - Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture N/A
Completed NCT03420716 - Symbiotic Yogurt, Calcium Absorption and Bone Health in Young Adult Women N/A
Unknown status NCT01913834 - Nasally and sc Administered Teriparatide in Healthy Volunteers Phase 1
Completed NCT02003716 - DeFRA Questionnaire as an Anamnestic Form N/A
Not yet recruiting NCT01854086 - Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday N/A
Completed NCT01401556 - C-STOP Fracture Trial N/A
Completed NCT02143674 - Muscle Strengthening Exercises and Global Stretching in Elderly N/A