Glucocorticoids and Bone in Graves' Ophthalmopathy
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Patients 30 patients with Graves' ophthalmopathy in which treatment with intravenous methylprednisolone is indicated |
Drug: Methylprednisolone
Intravenous methylprednisolone
|
Outcome Measures
Primary Outcome Measures
- Lumbar spine bone mineral density [12 weeks]
Change in lumbar spine bone mineral density from baseline to week 12
Secondary Outcome Measures
- Femoral neck bone mineral density [12 weeks]
Change in femoral neck bone mineral density from baseline to week 12
- Total hip bone mineral density [12 weeks]
Change in total hip bone mineral density from baseline to week 12
- Bone turnover [12 weeks]
Change in bone turnover measured by the biochemical markers CTx and P1NP
- Bone structure [12 weeks]
Change in bone structure measured by high-resolution peripheral quantitative computed tomography
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Aarhus University Hospital | Aarhus C | Central Denmark Region | Denmark | 8000 |
2 | Odense University Hospital | Odense | Denmark | 5000C |
Sponsors and Collaborators
- Torben Harsløf
- Odense University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GRO-BONE1