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

NCT02252679 | Completed

• 1 other identifier: UZ Leuven - s56719
• Study Type: observational
• Target: 54
• Locations: 2 countries
• Sites: 2

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.

Conditions

Bone Diseases; Osteomalacia; Osteoporosis

Keywords

Bone Turnover Markers; Calcium Isotopes

Outcome Measures

Primary Outcomes (1)

• Likelihood ratio (LR) of urinary calcium δ44/40 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 Outcomes (2)

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

  follow-up will vary on clinical basis, with expected averages of 1 year (for osteoporosis) to 3 months (for other conditions)

• 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

  follow-up will vary on clinical basis, with expected averages of 1 year (for osteoporosis) to 3 months (for other conditions)

Other Outcomes (2)

• Inter- and intra-assay variability of plasma and urine calcium δ44/40 Ca (‰) values

  follow-up will vary on clinical basis, with expected averages of 1 year (for osteoporosis) to 3 months (for other conditions)

• calcium δ44/40 Ca (‰) values of human bone samples

  before and 1 year after kidney transplantation

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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) \[for osteoporosis and calcium malabsorption patients\]

You may not qualify if:

• inability to provide written informed consent

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• GEOMAR-Helmholtz Centre for Ocean Research: collaborator

Study Sites (2)

UZ Leuven

Leuven, 3000, Belgium

Location

GEOMAR-Helmholtz Centre for Ocean Research

Kiel, 24148, Germany

Location

Related 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.

  PMID: 32454455 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, serum, spot urine and/or 24h urine collection samples

MeSH Terms

Conditions

Bone Diseases; Osteomalacia; Osteoporosis

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Rickets; Bone Diseases, Metabolic; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Study Officials

• Dirk Vanderschueren, MD, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: September 30, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 6, 2020

Record last verified: 2020-10

Locations

BE (1); DE (1)