Glucocorticoids and Bone in Graves' Ophthalmopathy

Completed

• Conditions: Graves Ophthalmopathy
• Interventions: Drug: Methylprednisolone

• Registration Number: NCT03122847
• Lead Sponsor: Torben Harsløf

Brief 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.

Study Timeline

• Study First Submitted: 2017-04-18
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-21
• Study Start: 2017-06-07
• Primary Completion: 2022-07-14
• Results First Submitted: 2023-06-14
• Study Completion: 2024-02-01
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-26
• Last Update Submitted: 2025-02-26
• Results First Posted: 2025-03-19
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Methylprednisolone	30 patients with Graves' ophthalmopathy in which treatment with intravenous methylprednisolone is indicated

Primary Outcome Measures

Name	Time	Method
Percent Change Lumbar Spine Bone Mineral Density	12 weeks	Percent change in lumbar spine bone mineral density from baseline to week 12

Secondary Outcome Measures

Name	Time	Method
Percent Change Femoral Neck Bone Mineral Density	12 weeks	Percent change in femoral neck bone mineral density from baseline to week 12
Percent Change Total Hip Bone Mineral Density	12 weeks	Percent change in total hip bone mineral density from baseline to week 12
Bone Resorption	12 weeks	Change in bone resorption measured by the biochemical marker C-terminal telopeptide of type 1 collagen (CTx) where higher measures show increased bone resorption that decreases bone mineral density and strength.
Bone Formation	12 weeks	Change in Bone Formation Measured by the Biochemical Marker procollagen type I N-propeptide (P1NP) where higher measures in combination with increased CTx (see measure 4) show increased bone resorption that decrease bone mineral density and strength but where lower levels may suggest decreased bone formation that may alsodecrease bone mineral density and strength.
Percent Change in Bone Structure at the Radius	12 weeks	Percent change in radial cortical volumteric BMD measured by high-resolution peripheral quantitative computed tomography
Percent Change in Bone Structure at the Tibia	12 weeks	Percent change in tibial cortical volumetric BMD measured by high-resolution peripheral quantitative computed tomography

Trial Locations

Locations (2)

Odense University Hospital; 🇩🇰 Odense, Denmark

Aarhus University Hospital; 🇩🇰 Aarhus C, Central Denmark Region, Denmark