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NCT Number: NCT03122847

Glucocorticoids and Bone in Graves' Ophthalmopathy

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.

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Key information

Conditions

Graves Ophthalmopathy Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Exophthalmos Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Goiter Graves Disease Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Aarhus C, Central Jutland, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methylprednisolone

Drug

Intravenous methylprednisolone

Other names: Solu Medrol

Primary outcomes

  1. Percent Change Lumbar Spine Bone Mineral Density

    Time frame: 12 weeks

    Percent change in lumbar spine bone mineral density from baseline to week 12

Secondary outcomes

  1. Percent Change Femoral Neck Bone Mineral Density

    Time frame: 12 weeks

    Percent change in femoral neck bone mineral density from baseline to week 12

  2. Percent Change Total Hip Bone Mineral Density

    Time frame: 12 weeks

    Percent change in total hip bone mineral density from baseline to week 12

  3. Bone Resorption

    Time frame: 12 weeks

    Change in bone resorption measured by the biochemical marker C-terminal telopeptide of type 1 collagen (CTx) where higher measures show increased bone resorption that decreases bone mineral density and strength.

  4. Bone Formation

    Time frame: 12 weeks

    Change in Bone Formation Measured by the Biochemical Marker procollagen type I N-propeptide (P1NP) where higher measures in combination with increased CTx (see measure 4) show increased bone resorption that decrease bone mineral density and strength but where lower levels may suggest decreased bone formation that may alsodecrease bone mineral density and strength.

  5. Percent Change in Bone Structure at the Radius

    Time frame: 12 weeks

    Percent change in radial cortical volumteric BMD measured by high-resolution peripheral quantitative computed tomography

  6. Percent Change in Bone Structure at the Tibia

    Time frame: 12 weeks

    Percent change in tibial cortical volumetric BMD measured by high-resolution peripheral quantitative computed tomography

Sponsors and collaborators

Lead sponsor

Torben Harsløf

Other

Collaborators

  • Odense University Hospital

Registry information

Official study title

The Effect of 4.5 Gram Methylprednisolone Administered Once Weekly for 12 Weeks on Bone Metabolism in Graves´ Ophthalmopathy

Important dates

Study start
2017
Primary completion
2022
Study completion
2024
First posted
Apr 21, 2017
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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