Glucocorticoids and Bone in Graves' Ophthalmopathy

Sponsor
Torben Harsløf (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03122847
Collaborator
Odense University Hospital (Other)
30
2
72.8
15
0.2

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

Study Type:
Observational
Anticipated 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 :
Jun 7, 2017
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2023

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

  1. Lumbar spine bone mineral density [12 weeks]

    Change in lumbar spine bone mineral density from baseline to week 12

Secondary Outcome Measures

  1. Femoral neck bone mineral density [12 weeks]

    Change in femoral neck bone mineral density from baseline to week 12

  2. Total hip bone mineral density [12 weeks]

    Change in total hip bone mineral density from baseline to week 12

  3. Bone turnover [12 weeks]

    Change in bone turnover measured by the biochemical markers CTx and P1NP

  4. Bone structure [12 weeks]

    Change in bone structure measured by high-resolution peripheral quantitative computed tomography

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Responsible Party:
Torben Harsløf, MD, PhD, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT03122847
Other Study ID Numbers:
  • GRO-BONE1
First Posted:
Apr 21, 2017
Last Update Posted:
Feb 22, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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:

Study Results

No Results Posted as of Feb 22, 2022