Graves OphthalmopathyNCT03122847
Glucocorticoids and Bone in Graves' Ophthalmopathy
An observational study of Graves Ophthalmopathy, run by Torben Harsløf at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graves Ophthalmopathy
- What is being tested?
- Methylprednisolone
- Type of treatment
- Injection or infusion
- How many people
- 39 participants
- Where
- 2 sitesDenmark
- Study dates
- 7 Jun 2017to 1 Feb 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 adult patients with Graves' Ophthalopathy
Who may be able to join
- Graves Ophthalmopathy that requires treatment with intra-venous methylprednisolone
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus University Hospital
Aarhus C, Central Jutland, 8000
Odense University Hospital
Odense, 5000C
About this study
Official title: The Effect of 4.5 Gram Methylprednisolone Administered Once Weekly for 12 Weeks on Bone Metabolism 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.
Read the 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.
- Conditions
- Graves Ophthalmopathy
- Being tested
- Methylprednisolone
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Solu Medrol
Intravenous methylprednisolone
| Study group | Role | What they receive |
|---|---|---|
| Patients | 30 patients with Graves' ophthalmopathy in which treatment with intravenous methylprednisolone is indicated Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change Lumbar Spine Bone Mineral Density
Percent change in lumbar spine bone mineral density from baseline to week 12
Measured: 12 weeks
Secondary outcomes (6)
Percent Change Femoral Neck Bone Mineral Density
Percent change in femoral neck bone mineral density from baseline to week 12
Measured: 12 weeks
Percent Change Total Hip Bone Mineral Density
Percent change in total hip bone mineral density from baseline to week 12
Measured: 12 weeks
Bone Resorption
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.
Measured: 12 weeks
Bone Formation
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.
Measured: 12 weeks
Percent Change in Bone Structure at the Radius
Percent change in radial cortical volumteric BMD measured by high-resolution peripheral quantitative computed tomography
Measured: 12 weeks
Percent Change in Bone Structure at the Tibia
Percent change in tibial cortical volumetric BMD measured by high-resolution peripheral quantitative computed tomography
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start7 Jun 2017
- Primary completion14 Jul 2022
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Graves OphthalmopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Torben Harsløf
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Sponsor-investigator, Torben Harsløf, Aarhus University Hospital
- Investigators
- Torben Harsløf, MD, PhD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122847
- Sponsor's protocol ID
- GRO-BONE1
- Status last verified
- Feb 2025
- First submitted
- 18 Apr 2017
- Last updated
- 19 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 4.5 Gram Methylprednisolone Administered Once Weekly for 12 Weeks on Bone Metabolism in Graves´ Ophthalmopathy
- ClinicalTrials.gov ID
- NCT03122847
- Acronym / sponsor ID
- GRO-BONE1
- Conditions
- Graves Ophthalmopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Torben HarsløfUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- 7 Jun 2017 (actual)
- Primary completion
- 14 Jul 2022 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Posted 19 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Drug: Methylprednisolone30 patients with Graves' ophthalmopathy in which treatment with intravenous methylprednisolone is indicated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 adult patients with Graves' Ophthalopathy
Key inclusion criteria (1 listed)
- Graves Ophthalmopathy that requires treatment with intra-venous methylprednisolone
Key exclusion criteria (7 listed)
- Treatment with osteoporosis medication
- Primary hyperparathyroidism
- Hypoparathyroidism
- Vitamin D < 20mmol/L
- Estimated glomerular filtration rate < 30 mL/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylprednisoloneAlso: Solu MedrolIntravenous methylprednisolone | Drug | Patients |
Primary outcome
Percent Change Lumbar Spine Bone Mineral Density
Time frame: 12 weeks
Percent change in lumbar spine bone mineral density from baseline to week 12
6 secondary outcomes
Percent Change Femoral Neck Bone Mineral Density
Time frame: 12 weeks
Percent Change Total Hip Bone Mineral Density
Time frame: 12 weeks
Bone Resorption
Time frame: 12 weeks
Bone Formation
Time frame: 12 weeks
Percent Change in Bone Structure at the Radius
Time frame: 12 weeks
Percent Change in Bone Structure at the Tibia
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Graves Ophthalmopathy
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A Study to Learn About The Effects of Felzartamab on Thyroid Function and Its Safety in Adults With Graves' Disease Ages 18 to 75 Years Old
Graves' Disease
Not yet recruitingPhase 2/3
An Open-Label Study to Determine if BHV-1300 is Safe in Adults With Graves' Disease
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A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease.
Graves Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torben Harsløf, MD, PhD principal investigator
University of Aarhus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graves Ophthalmopathy, run by Torben Harsløf at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change Lumbar Spine Bone Mineral Density (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.