NCT03122847

Glucocorticoids and Bone in Graves' Ophthalmopathy

The Effect of 4.5 Gram Methylprednisolone Administered Once Weekly for 12 Weeks on Bone Metabolism in Graves´ Ophthalmopathy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 39 (actual)
• Sponsor: Torben Harsløf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Systemic glucocorticoid increases bone resorption and decreases bone formation and thereby decreases bone mineral density and increases fracture risk. This effect is evident with a daily dose of 5 mg for three months or an accumulated dose of 450mg. There is, however, less evidence that intermittent use of glucocorticoids is harmful to bone. Graves orbitopathy is treated with a weekly infusion of the glucocorticoid methylprednisolone and the accumulated dose over a 12-week course sums up to 4,500mg. The investigators therefore want to investigate if that treatment regimen affects bone turnover, bone mineral density, or bone structure in 30 patients with Graves' orbitopathy.

Conditions

• Graves Ophthalmopathy

Interventions

Type	Name	Description
DRUG	Methylprednisolone	Intravenous methylprednisolone

Timeline

• Start date: 2017-06-07
• Primary completion: 2022-07-14
• Completion: 2024-02-01
• First posted: 2017-04-21
• Last updated: 2025-03-19
• Results posted: 2025-03-19

Locations

2 sites across 1 country: Denmark

Regulatory

• FDA-regulated drug study