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| Name | Class |
|---|---|
| GEOMAR-Helmholtz Centre for Ocean Research | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Likelihood ratio (LR) of plasma 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, BMD results, bone turnover markers and response to treatments. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Tertiary care clinical convenience sample Healthy volunteers recruited from the communities in Leuven and neighbouring cities Siblings, parents or other relatives of patients
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| Name | Affiliation | Role |
|---|---|---|
| Dirk Vanderschueren, MD, PhD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | 3000 | Belgium | |||
| GEOMAR-Helmholtz Centre for Ocean Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32454455 | Background | 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. |
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| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D010018 | Osteomalacia |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D012279 | Rickets |
| D001851 | Bone Diseases, Metabolic |
| D008659 | Metabolic Diseases |
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Plasma, serum, spot urine and/or 24h urine collection samples
| 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 | 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) |
Secondary use of bone biopsy samples obtained in the Leuven Bone Biopsy Program (NCT01886950)
| before and 1 year after kidney transplantation |
| Kiel |
| 24148 |
| Germany |
| D009750 |
| Nutritional and Metabolic Diseases |
| D002128 | Calcium Metabolism Disorders |
| D014808 | Vitamin D Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |