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Calcium isotope determination in the osteological basic diagnostics in patients with rheumatoid arthritis: the exploratory monocentric CORAL study

Calcium isotope determination in the osteological basic diagnostics in patients with rheumatoid arthritis: the exploratory monocentric CORAL study - CORAL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00035244
Enrollment
200
Registered
2024-10-08
Start date
2025-01-02
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis

Interventions

Group 1: Patients with rheumatoid arthritis and osteoporosis measured using DXA (Dual Energy X-ray Absorptiometry)

Sponsors

Justus-Liebig-Universität Gießen, Campus Kerckhoff
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Written informed consent to participate in the study. 2. Understanding of the study procedures and willingness to adhere to all procedures throughout the study. 3. Diagnosis of RA that meets the 2010 EULAR/ACR classification criteria. 4. Recently conducted (max. 2 weeks prior) osteological baseline diagnostics, including bone mineral density measurement using DXA.

Exclusion criteria

Exclusion criteria: a. Diagnosis of another rheumatological disease other than RA b. Known osteoporosis c. Present or past osteoporotic fractures d. Current implementation of an osteospecific therapy (antiresorptive or anabolic) e. Intake of glucocorticoids > 5 mg prednisolone equivalent/day f. Calcium supplementation > 1000 mg/day g. Vitamin D supplementation > 5000 IU/day h. Severe vitamin D deficiency (cholecalciferol < 15 µg/l) i. Rickets j. Type I diabetes mellitus k. Intake of growth hormones, estrogens, aromatase inhibitors, other tumor therapy l. Intake of SSRIs m. Heart failure with a left ventricular ejection fraction < 35% n. Hyperthyroidism o. Plasmacytoma or monoclonal gammopathy of uncertain significance p. Anorexia nervosa (BMI < 18.5 kg/m²) q. Employee or direct relative of an employee of the study center or steering committee r. Previous participation in this clinical study s. Planned extended stay outside the region that prevents adherence to the study protocol t. Insurmountable language barrier u. Lack of consent

Design outcomes

Primary

MeasureTime frame
Determination of the calcium isotope ratio from blood (d44/42CaBlood)

Secondary

MeasureTime frame
• Determination of the calcium isotope ratio from urine (d44/42CaUrin) • Determination of the calcium isotope ratio depending on sex, disease activity of RA, functional health, presence of autoantibodies of RA (RF & ACPA), and administered prednisolone therapy • Comparison of the calcium isotope ratio with parameters of bone metabolism

Countries

Germany

Contacts

Public ContactPhilipp Klemm

Justus-Liebieg-Universität, Campus Kerckhoff

p.klemm@kerckhoff-klinik.de06032/996-0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026