Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02252679
Recruitment Status : Recruiting
First Posted : September 30, 2014
Last Update Posted : May 18, 2018
Sponsor:
Collaborator:
GEOMAR-Helmholtz Centre for Ocean Research
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.

Condition or disease
Bone Diseases Osteomalacia Osteoporosis

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
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 Start Date : October 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort
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)
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.
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
Normal control subjects
N=40 Men and women ≤ 40 years recruited from the population



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. Inter- and intra-assay variability of plasma and urine calcium δ44/40 Ca (‰) values [ Time Frame: follow-up will vary on clinical basis, with expected averages of 1 year (for osteoporosis) to 3 months (for other conditions) ]
  2. calcium δ44/40 Ca (‰) values of human bone samples [ Time Frame: before and 1 year after kidney transplantation ]
    Secondary use of bone biopsy samples obtained in the Leuven Bone Biopsy Program (NCT01886950)


Biospecimen Retention:   Samples Without DNA
Plasma, serum, spot urine and/or 24h urine collection samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252679


Contacts
Layout table for location contacts
Contact: Michaël R Laurent, MD +3216330255 michael.laurent@uzleuven.be
Contact: Dirk Vanderschueren, MD, PhD +3216346987 dirk.vanderschueren@uzleuven.be

Locations
Layout table for location information
Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Principal Investigator: Vanderschueren Dirk, MD, PhD         
Sub-Investigator: Michaël R Laurent, MD         
Sub-Investigator: Evelien Gielen, MD         
Sub-Investigator: Marian Dejaeger, MD         
Sub-Investigator: Brigitte Decallonne, MD, PhD         
Sub-Investigator: Frank Luyten, MD, PhD         
Sub-Investigator: Pieter Evenepoel, MD, PhD         
Germany
GEOMAR-Helmholtz Centre for Ocean Research Recruiting
Kiel, Germany, 24148
Contact: Anton Eisenhauer, PhD    +49 431 600 2282    aeisenhauer@geomar.de   
Principal Investigator: Anton Eisenhauer, PhD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
GEOMAR-Helmholtz Centre for Ocean Research
Investigators
Layout table for investigator information
Principal Investigator: Dirk Vanderschueren, MD, PhD UZ Leuven

Layout table for additonal information
Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02252679     History of Changes
Other Study ID Numbers: UZ Leuven - s56719
First Posted: September 30, 2014    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

Keywords provided by Universitaire Ziekenhuizen Leuven:
Bone Turnover Markers
Calcium Isotopes

Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoporosis
Bone Diseases
Osteomalacia
Bone Diseases, Metabolic
Musculoskeletal Diseases
Metabolic Diseases
Rickets
Calcium Metabolism Disorders
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Calcium
Calcium, Dietary
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents