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| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | 30 patients with Graves' ophthalmopathy in which treatment with intravenous methylprednisolone is indicated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone | Drug | Intravenous methylprednisolone |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change Lumbar Spine Bone Mineral Density | Percent change in lumbar spine bone mineral density from baseline to week 12 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change Femoral Neck Bone Mineral Density | Percent change in femoral neck bone mineral density from baseline to week 12 | 12 weeks |
| Percent Change Total Hip Bone Mineral Density | Percent change in total hip bone mineral density from baseline to week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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30 adult patients with Graves' Ophthalopathy
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| Name | Affiliation | Role |
|---|---|---|
| Torben Harsløf, MD, PhD | University of Aarhus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus C | Central Jutland | 8000 | Denmark | ||
| Odense University Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients | 32 patients with Graves' ophthalmopathy in which treatment with intravenous methylprednisolone is indicated Methylprednisolone: Intravenous methylprednisolone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients | 32 patients with Graves' ophthalmopathy in which treatment with intravenous methylprednisolone is indicated Methylprednisolone: Intravenous methylprednisolone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change Lumbar Spine Bone Mineral Density | Percent change in lumbar spine bone mineral density from baseline to week 12 | Posted | Mean | Standard Deviation | Percentage change | 12 weeks |
|
|
24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients | 32 patients with Graves' ophthalmopathy in which treatment with intravenous methylprednisolone is indicated Methylprednisolone: Intravenous methylprednisolone |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Torben Harsløf | Aarhus University Hospital | +4578455470 | torbhars@rm.dk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2017 | Jun 14, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D006111 | Graves Disease |
| D005094 | Exophthalmos |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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Blood samples stored at -80C for batch analysis at study completion
| 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. | 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. | 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 | 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 | 12 weeks |
| Odense |
| 5000C |
| Denmark |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Lumbar spine bone mineral density | Mean | Standard Deviation | g/cm2 |
|
| Femoral neck bone mineral density | Mean | Standard Deviation | g/cm2 |
|
| Total hip bone mineral density | Mean | Standard Deviation | g/cm2 |
|
| Tri-iodothyronine | Mean | Standard Deviation | nmol/L |
|
| Thyroxine | Mean | Standard Deviation | nmol/L |
|
|
| Secondary | Percent Change Femoral Neck Bone Mineral Density | Percent change in femoral neck bone mineral density from baseline to week 12 | Posted | Mean | Standard Deviation | Percentage change | 12 weeks |
|
|
|
| Secondary | Percent Change Total Hip Bone Mineral Density | Percent change in total hip bone mineral density from baseline to week 12 | Posted | Mean | Standard Deviation | Percentage change | 12 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | microgram/L | 12 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | microgram/L | 12 weeks |
|
|
|
| Secondary | Percent Change in Bone Structure at the Radius | Percent change in radial cortical volumteric BMD measured by high-resolution peripheral quantitative computed tomography | Posted | Mean | Standard Deviation | Percentage change | 12 weeks |
|
|
|
| Secondary | Percent Change in Bone Structure at the Tibia | Percent change in tibial cortical volumetric BMD measured by high-resolution peripheral quantitative computed tomography | Posted | Mean | Standard Deviation | Percentage change | 12 weeks |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
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| D009916 |
| Orbital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |