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Trial record 6 of 17 for:    "Hyperthyroidism" | "Neuroprotective Agents"

Glucocorticoids and Bone in Graves' Ophthalmopathy

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ClinicalTrials.gov Identifier: NCT03122847
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : January 9, 2019
Sponsor:
Collaborator:
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.


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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 : January 2020
Estimated Study Completion Date : November 2020


Group/Cohort Intervention/treatment
Patients
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


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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
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

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 ClinicalTrials.gov identifier (NCT number): NCT03122847


Contacts
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Contact: Torben Harsløf, MD, PhD +4578467605 torbhars@rm.dk
Contact: Eva Ebbehøj, MD, PhD +4578467605 eva.ebbehøj@aarhus.rm.dk

Locations
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Denmark
Aarhus University Hospital Recruiting
Aarhus C, Central Denmark Region, Denmark, 8000
Contact: Torben Harsløf, MD, PhD       torbhars@rm.dk   
Contact: Eva Ebbehøj, MD, PhD       eva.ebbehoj@rm.dk   
Odense University Hospital Recruiting
Odense, Denmark, 5000C
Contact: Morten Nielsen, MD, PhD       frostnielsen@yahoo.com   
Sponsors and Collaborators
Torben Harsløf
Odense University Hospital

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Responsible Party: Torben Harsløf, MD, PhD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT03122847     History of Changes
Other Study ID Numbers: GRO-BONE1
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Hyperthyroidism
Neuroprotective Agents
Graves Ophthalmopathy
Eye Diseases
Eye Diseases, Hereditary
Graves Disease
Exophthalmos
Orbital Diseases
Genetic Diseases, Inborn
Goiter
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists