Glucocorticoids and Bone in Graves' Ophthalmopathy

Graves Ophthalmopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03122847
• Other study ID #: GRO-BONE1
• Status: Active, not recruiting
• Start date: June 7, 2017
• Est. completion date: July 2023

Study information

• Verified date: February 2023
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: July 2023
• Est. primary completion date: July 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Graves Ophthalmopathy that requires treatment with intra-venous methylprednisolone

Exclusion Criteria:

• Treatment with osteoporosis medication

• Primary hyperparathyroidism

• Hypoparathyroidism

• Vitamin D < 20mmol/L

• eGFR < 30

• Liver disease

• Peroral treatment with glucocorticoids within last three months prior to inclusion

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy

Intervention

Drug:
• Methylprednisolone
Intravenous methylprednisolone

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus C	Central Denmark Region
Denmark	Odense University Hospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
Torben Harsløf	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lumbar spine bone mineral density	Change in lumbar spine bone mineral density from baseline to week 12	12 weeks
Secondary	Femoral neck bone mineral density	Change in femoral neck bone mineral density from baseline to week 12	12 weeks
Secondary	Total hip bone mineral density	Change in total hip bone mineral density from baseline to week 12	12 weeks
Secondary	Bone turnover	Change in bone turnover measured by the biochemical markers CTx and P1NP	12 weeks
Secondary	Bone structure	Change in bone structure measured by high-resolution peripheral quantitative computed tomography	12 weeks