Trial · NCT03122847
Glucocorticoids and Bone in Graves' Ophthalmopathy
NCT03122847, Completed, Torben Harsløf; results first posted 2025-03-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Glucocorticoids and Bone in Graves' Ophthalmopathy. Trials, record NCT03122847. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03122847
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Glucocorticoids and Bone in Graves' Ophthalmopathy
- NCT number
- NCT03122847
- Status
- Completed
- Enrollment
- 39 participants, actual
- Lead sponsor
- Torben Harsløf
- Conditions
- Graves Ophthalmopathy
- Interventions
- Methylprednisolone
- First posted
- 2017-04-21
- Last updated
- 2025-03-19
- Results first posted
- 2025-03-19
- Limitations and caveats
Follow up corresponds to the treatment length of the disease but may have been too short to fully elucidate the effect of treatment on bone mass and structure. Moreover, the study design does not allow distinction of the effect of treatment with methylprednisolone and treatment of the underlying disease on bone.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change Lumbar Spine Bone Mineral Density | 12 weeks | Percent change in lumbar spine bone mineral density from baseline to week 12 |
| Secondary | Percent Change Femoral Neck Bone Mineral Density | 12 weeks | Percent change in femoral neck bone mineral density from baseline to week 12 |
| Secondary | Percent Change Total Hip Bone Mineral Density | 12 weeks | Percent change in total hip bone mineral density from baseline to week 12 |
| Secondary | Bone Resorption | 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. |
| Secondary | Bone Formation | 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. |
| Secondary | Percent Change in Bone Structure at the Radius | 12 weeks | Percent change in radial cortical volumteric BMD measured by high-resolution peripheral quantitative computed tomography |
| Secondary | Percent Change in Bone Structure at the Tibia | 12 weeks | Percent change in tibial cortical volumetric BMD measured by high-resolution peripheral quantitative computed tomography |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change Lumbar Spine Bone Mineral Density | 12 weeks | Percentage change | MEAN | |
| SECONDARY | Percent Change Femoral Neck Bone Mineral Density | 12 weeks | Percentage change | MEAN | |
| SECONDARY | Percent Change Total Hip Bone Mineral Density | 12 weeks | Percentage change | MEAN | |
| SECONDARY | Bone Resorption | 12 weeks | microgram/L | MEAN | |
| SECONDARY | Bone Formation | 12 weeks | microgram/L | MEAN | |
| SECONDARY | Percent Change in Bone Structure at the Radius | 12 weeks | Percentage change | MEAN | |
| SECONDARY | Percent Change in Bone Structure at the Tibia | 12 weeks | Percentage change | MEAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change Lumbar Spine Bone Mineral Density | Patients | 1.37 | Standard Deviation 4.52 | Percentage change | |
| Percent Change Femoral Neck Bone Mineral Density | Patients | -0.32 | Standard Deviation 4.75 | Percentage change | |
| Percent Change Total Hip Bone Mineral Density | Patients | -0.18 | Standard Deviation 2.62 | Percentage change | |
| Bone Resorption | Patients | -0.27 | Standard Deviation 0.32 | microgram/L | |
| Bone Formation | Patients | -52.3 | Standard Deviation 97.5 | microgram/L | |
| Percent Change in Bone Structure at the Radius | Patients | 0.98 | Standard Deviation 0.38 | Percentage change | |
| Percent Change in Bone Structure at the Tibia | Patients | 1.35 | Standard Deviation 0.5 | Percentage change |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Patients | 39 | |
| Overall Study | COMPLETED | Patients | 32 | |
| Overall Study | NOT COMPLETED | Patients | 7 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Patients | 0 | 32 |
| Total, other adverse events | Patients | 0 | 32 |
| Total, serious adverse events | Patients | 0 | 32 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03122847
GET https://conductscience.org/api/trials/v1/NCT03122847/registered