Glucocorticoids and Bone in Graves' Ophthalmopathy

Torben Harsløf

Status: Completed

Conditions: Graves Ophthalmopathy

Treatments: Drug: Methylprednisolone

Study type: Observational

Funder types: Other

Identifiers

NCT03122847

GRO-BONE1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

39 participants in 1 patient group

Patients

Description:

30 patients with Graves' ophthalmopathy in which treatment with intravenous methylprednisolone is indicated

Treatment:

Drug: Methylprednisolone