Glucocorticoids and Bone in Graves' Ophthalmopathy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-07

Study Completion Date

2024-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Identifying Individuals At Risk of Glucocorticoid-Induced Impairment of Bone Disease

NCT06421597

Osteoporosis Secondary

RECRUITING PHASE2

Can Parathyroid Hormone Injections Reverse Glucocorticoid-induced Osteoporosis

NCT00004993

Osteoporosis

COMPLETED PHASE2

Prevention of Steroid-Induced Osteoporosis in Children

NCT00022841

Osteoporosis

TERMINATED PHASE1/PHASE2

Effects of a Liquid Meal and Gut Hormones (GIP and GLP-2) on Bone Remodeling in Participants With Hypoparathyroidism.

NCT03728959

Hypoparathyroidism

COMPLETED NA

Effects of Genistein Aglycone in Glucocorticoid Induced Osteoporosis

NCT03040531

Osteoporosis, Steroid Induced

UNKNOWN PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Graves Ophthalmopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients

30 patients with Graves' ophthalmopathy in which treatment with intravenous methylprednisolone is indicated

Methylprednisolone

Intervention Type DRUG

Intravenous methylprednisolone

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Methylprednisolone

Intravenous methylprednisolone

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Solu Medrol

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Graves Ophthalmopathy that requires treatment with intra-venous methylprednisolone

Exclusion Criteria

* Treatment with osteoporosis medication
* Primary hyperparathyroidism
* Hypoparathyroidism
* Vitamin D \< 20mmol/L
* Estimated glomerular filtration rate \< 30 mL/min
* Liver disease
* Peroral treatment with glucocorticoids within last three months prior to inclusion

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No