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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03122847
Other study ID # GRO-BONE1
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 7, 2017
Est. completion date July 2023

Study information

Verified date February 2023
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date July 2023
Est. primary completion date July 14, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Graves Ophthalmopathy that requires treatment with intra-venous methylprednisolone Exclusion Criteria: - Treatment with osteoporosis medication - Primary hyperparathyroidism - Hypoparathyroidism - Vitamin D < 20mmol/L - eGFR < 30 - Liver disease - Peroral treatment with glucocorticoids within last three months prior to inclusion

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Methylprednisolone
Intravenous methylprednisolone

Locations

Country Name City State
Denmark Aarhus University Hospital Aarhus C Central Denmark Region
Denmark Odense University Hospital Odense

Sponsors (2)

Lead Sponsor Collaborator
Torben Harsløf Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lumbar spine bone mineral density Change in lumbar spine bone mineral density from baseline to week 12 12 weeks
Secondary Femoral neck bone mineral density Change in femoral neck bone mineral density from baseline to week 12 12 weeks
Secondary Total hip bone mineral density Change in total hip bone mineral density from baseline to week 12 12 weeks
Secondary Bone turnover Change in bone turnover measured by the biochemical markers CTx and P1NP 12 weeks
Secondary Bone structure Change in bone structure measured by high-resolution peripheral quantitative computed tomography 12 weeks
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