Trial Outcomes & Findings for Glucocorticoids and Bone in Graves' Ophthalmopathy (NCT NCT03122847)

NCT ID: NCT03122847

Last Updated: 2025-03-19

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 39 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2025-03-19

Participant Flow

Participant milestones

Measure	Patients 32 patients with Graves' ophthalmopathy in which treatment with intravenous methylprednisolone is indicated Methylprednisolone: Intravenous methylprednisolone
Overall Study STARTED	39
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Patients n=32 Participants 32 patients with Graves' ophthalmopathy in which treatment with intravenous methylprednisolone is indicated Methylprednisolone: Intravenous methylprednisolone
Age, Continuous	52.9 Years STANDARD_DEVIATION 10.2 • n=32 Participants
Sex: Female, Male Female	21 Participants n=32 Participants
Sex: Female, Male Male	11 Participants n=32 Participants
Region of Enrollment Denmark	32 Participants n=32 Participants
Lumbar spine bone mineral density	1.0 g/cm2 STANDARD_DEVIATION 0.15 • n=32 Participants
Femoral neck bone mineral density	0.78 g/cm2 STANDARD_DEVIATION 0.11 • n=32 Participants
Total hip bone mineral density	0.91 g/cm2 STANDARD_DEVIATION 0.13 • n=32 Participants
Tri-iodothyronine	1.92 nmol/L STANDARD_DEVIATION 0.67 • n=32 Participants
Thyroxine	90.4 nmol/L STANDARD_DEVIATION 35.4 • n=32 Participants

PRIMARY outcome

Timeframe: 12 weeks

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

Outcome measures

Measure	Patients n=32 Participants 32 patients with Graves' ophthalmopathy in which treatment with intravenous methylprednisolone is indicated Methylprednisolone: Intravenous methylprednisolone
Percent Change Lumbar Spine Bone Mineral Density	1.37 Percentage change Standard Deviation 4.52

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Measure	Patients n=32 Participants 32 patients with Graves' ophthalmopathy in which treatment with intravenous methylprednisolone is indicated Methylprednisolone: Intravenous methylprednisolone
Percent Change Femoral Neck Bone Mineral Density	-0.32 Percentage change Standard Deviation 4.75

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Measure	Patients n=32 Participants 32 patients with Graves' ophthalmopathy in which treatment with intravenous methylprednisolone is indicated Methylprednisolone: Intravenous methylprednisolone
Percent Change Total Hip Bone Mineral Density	-0.18 Percentage change Standard Deviation 2.62

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Patients n=32 Participants 32 patients with Graves' ophthalmopathy in which treatment with intravenous methylprednisolone is indicated Methylprednisolone: Intravenous methylprednisolone
Bone Resorption	-0.27 microgram/L Standard Deviation 0.32

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Patients n=32 Participants 32 patients with Graves' ophthalmopathy in which treatment with intravenous methylprednisolone is indicated Methylprednisolone: Intravenous methylprednisolone
Bone Formation	-52.3 microgram/L Standard Deviation 97.5

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Measure	Patients n=32 Participants 32 patients with Graves' ophthalmopathy in which treatment with intravenous methylprednisolone is indicated Methylprednisolone: Intravenous methylprednisolone
Percent Change in Bone Structure at the Radius	0.98 Percentage change Standard Deviation 0.38

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Measure	Patients n=32 Participants 32 patients with Graves' ophthalmopathy in which treatment with intravenous methylprednisolone is indicated Methylprednisolone: Intravenous methylprednisolone
Percent Change in Bone Structure at the Tibia	1.35 Percentage change Standard Deviation 0.5

Adverse Events

Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Torben Harsløf

Aarhus University Hospital

Phone: +4578455470

Email: torbhars@rm.dk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place