N/A
Completed N=39
Glucocorticoids and Bone in Graves' Ophthalmopathy
Source: ClinicalTrials.gov NCT03122847 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Percent Change Lumbar Spine Bone Mineral Density — 1.37 Percentage change
Summary
Continuous use of systemic glucocorticoids decreases bone mineral density and increases fracture risk. Graves' orbitopathy is treated with weekly infusion of high-dose intravenous glucocorticoid. The investigators aim at investigating whether this treatment regimen also affects bone metabolism.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change Lumbar Spine Bone Mineral Density |
1.37 | — |
| SECONDARY Percent Change Femoral Neck Bone Mineral Density |
-0.32 | — |
| SECONDARY Percent Change Total Hip Bone Mineral Density |
-0.18 | — |
| SECONDARY Bone Resorption |
-0.27 | — |
| SECONDARY Bone Formation |
-52.3 | — |
| SECONDARY Percent Change in Bone Structure at the Radius |
0.98 | — |
| SECONDARY Percent Change in Bone Structure at the Tibia |
1.35 | — |
Eligibility Criteria
Inclusion Criteria
- Graves Ophthalmopathy that requires treatment with intra-venous methylprednisolone
Exclusion Criteria
- Treatment with osteoporosis medication
- Primary hyperparathyroidism
- Hypoparathyroidism
- Vitamin D < 20mmol/L
- Estimated glomerular filtration rate < 30 mL/min
- Liver disease
- Peroral treatment with glucocorticoids within last three months prior to inclusion
Data sourced from ClinicalTrials.gov (NCT03122847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.