Glucocorticoids and Bone in Graves' Ophthalmopathy

Torben Harsløf39 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Graves Ophthalmopathy

Interventions

MethylprednisoloneDRUG

Intravenous methylprednisolone

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Aarhus University Hospital

Aarhus C, Central Jutland, Denmark

Odense University Hospital

Odense, Denmark

Outcomes

Primary Outcomes

Percent Change Lumbar Spine Bone Mineral Density

Percent change in lumbar spine bone mineral density from baseline to week 12

Time frame: 12 weeks

Secondary Outcomes

Percent Change Femoral Neck Bone Mineral Density

Percent change in femoral neck bone mineral density from baseline to week 12

Time frame: 12 weeks

Percent Change Total Hip Bone Mineral Density

Percent change in total hip bone mineral density from baseline to week 12

Time frame: 12 weeks

Bone Resorption

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.

Time frame: 12 weeks

Bone Formation

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.

Time frame: 12 weeks

Percent Change in Bone Structure at the Radius

Percent change in radial cortical volumteric BMD measured by high-resolution peripheral quantitative computed tomography

Time frame: 12 weeks

Percent Change in Bone Structure at the Tibia

Percent change in tibial cortical volumetric BMD measured by high-resolution peripheral quantitative computed tomography

Data from ClinicalTrials.gov

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