COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Glucocorticoids and Bone in Graves' Ophthalmopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03122847
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : July 23, 2020
Odense University Hospital
Information provided by (Responsible Party):
Torben Harsløf, Aarhus University Hospital

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
Graves Ophthalmopathy Drug: Methylprednisolone

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of 4.5 Gram Methylprednisolone Administered Once Weekly for 12 Weeks on Bone Metabolism in Graves´ Ophthalmopathy
Actual Study Start Date : June 7, 2017
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : November 2021

Group/Cohort Intervention/treatment
30 patients with Graves' ophthalmopathy in which treatment with intravenous methylprednisolone is indicated
Drug: Methylprednisolone
Intravenous methylprednisolone

Primary Outcome Measures :
  1. Lumbar spine bone mineral density [ Time Frame: 12 weeks ]
    Change in lumbar spine bone mineral density from baseline to week 12

Secondary Outcome Measures :
  1. Femoral neck bone mineral density [ Time Frame: 12 weeks ]
    Change in femoral neck bone mineral density from baseline to week 12

  2. Total hip bone mineral density [ Time Frame: 12 weeks ]
    Change in total hip bone mineral density from baseline to week 12

  3. Bone turnover [ Time Frame: 12 weeks ]
    Change in bone turnover measured by the biochemical markers CTx and P1NP

  4. Bone structure [ Time Frame: 12 weeks ]
    Change in bone structure measured by high-resolution peripheral quantitative computed tomography

Biospecimen Retention:   Samples Without DNA
Blood samples stored at -80C for batch analysis at study completion

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
30 adult patients with Graves' Ophthalopathy

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03122847

Layout table for location contacts
Contact: Torben Harsløf, MD, PhD +4578467605
Contact: Eva Ebbehøj, MD, PhD +4578467605 eva.ebbehø

Layout table for location information
Aarhus University Hospital Recruiting
Aarhus C, Central Denmark Region, Denmark, 8000
Contact: Torben Harsløf, MD, PhD   
Contact: Eva Ebbehøj, MD, PhD   
Odense University Hospital Recruiting
Odense, Denmark, 5000C
Contact: Morten Nielsen, MD, PhD   
Sponsors and Collaborators
Torben Harsløf
Odense University Hospital
Layout table for additonal information
Responsible Party: Torben Harsløf, MD, PhD, Aarhus University Hospital Identifier: NCT03122847    
Other Study ID Numbers: GRO-BONE1
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Graves Ophthalmopathy
Eye Diseases
Eye Diseases, Hereditary
Graves Disease
Orbital Diseases
Genetic Diseases, Inborn
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents