N/A N=39

Glucocorticoids and Bone in Graves' Ophthalmopathy

Graves Ophthalmopathy

Bottom Line

View on ClinicalTrials.gov: NCT03122847 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: Percent Change Lumbar Spine Bone Mineral Density — 1.37 Percentage change

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Methylprednisolone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Torben Harsløf
Primary completion: Jul 2022

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	—

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.

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

View full record on ClinicalTrials.gov →

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.