Glucocorticoids and Bone in Graves' Ophthalmopathy
The Effect of 4.5 Gram Methylprednisolone Administered Once Weekly for 12 Weeks on Bone Metabolism in Graves´ Ophthalmopathy
1 other identifier
observational
39
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2017
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2017
CompletedFirst Posted
Study publicly available on registry
April 21, 2017
CompletedStudy Start
First participant enrolled
June 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedResults Posted
Study results publicly available
March 19, 2025
CompletedMarch 19, 2025
February 1, 2025
5.1 years
April 18, 2017
June 14, 2023
February 26, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change Lumbar Spine Bone Mineral Density
Percent change in lumbar spine bone mineral density from baseline to week 12
12 weeks
Secondary Outcomes (6)
Percent Change Femoral Neck Bone Mineral Density
12 weeks
Percent Change Total Hip Bone Mineral Density
12 weeks
Bone Resorption
12 weeks
Bone Formation
12 weeks
Percent Change in Bone Structure at the Radius
12 weeks
- +1 more secondary outcomes
Study Arms (1)
Patients
30 patients with Graves' ophthalmopathy in which treatment with intravenous methylprednisolone is indicated
Interventions
Eligibility Criteria
30 adult patients with Graves' Ophthalopathy
You may qualify if:
- Graves Ophthalmopathy that requires treatment with intra-venous methylprednisolone
You may not qualify if:
- Treatment with osteoporosis medication
- Primary hyperparathyroidism
- Hypoparathyroidism
- Vitamin D \< 20mmol/L
- Estimated glomerular filtration rate \< 30 mL/min
- Liver disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Torben Harsløflead
- Odense University Hospitalcollaborator
Study Sites (2)
Aarhus University Hospital
Aarhus C, Central Jutland, 8000, Denmark
Odense University Hospital
Odense, 5000C, Denmark
Biospecimen
Blood samples stored at -80C for batch analysis at study completion
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Follow up corresponds to the treatment length of the disease but may have been too short to fully elucidate the effect of treatment on bone mass and structure. Moreover, the study design does not allow distinction of the effect of treatment with methylprednisolone and treatment of the underlying disease on bone.
Results Point of Contact
- Title
- Dr. Torben Harsløf
- Organization
- Aarhus University Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Torben Harsløf, MD, PhD
University of Aarhus
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
April 18, 2017
First Posted
April 21, 2017
Study Start
June 7, 2017
Primary Completion
July 14, 2022
Study Completion
February 1, 2024
Last Updated
March 19, 2025
Results First Posted
March 19, 2025
Record last verified: 2025-02