99Tc-MDP for Thyroid-Associated Ophthalmopathy

Dalian University

Status and phase: Completed; Phase 4

Conditions: Thyroid-Associated Ophthalmopathy

Treatments: Drug: 99Tc-MDP(99Technetium-Methylenediphosphonate Injection); Drug: Methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT03948191

zsyy_nfm2-2017-10

Details and patient eligibility

About

To investigate the efficacy，safety and tolerability of 99Tc-MDP in comparison to Methylprednisolone, in the treatment of participants suffering from active moderate to severe TAO.

Enrollment: 50 patients

Sex: All

Ages: 18 to 76 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient age 18 Years to 76 Years;
• Fewer than 6 months from onset of TAO;
• Clinical diagnosis of Graves' disease associated with active TAO and a clinical activity score of ≥ 3;
• Moderate to severe TAO;
• No previous medical or surgical treatment, excluding local supportive measures and oral steroids if the maximum cumulative dose is less than 1000 mg methylprednisolone or equivalent with at least 6 weeks between last administration of oral steroids and randomization.

Exclusion criteria

• Optic neuropathy, severe orbital appearance and surgical;
• Extra-thyroid disease;
• Pregnant and children;
• Severe impairment of cardiac, hepatic and renal functions;
• Allergies;
• Other contraindications.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Methylprednisolone(ivMP)

Active Comparator group

Description:

Methylprednisolone(ivMP) 500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. once a week for 6 weeks.

Treatment:

Drug: Methylprednisolone

99Tc-MDP

Experimental group

Description:

99Tc-MDP 15mg i.v. infusion once a day for 10 days, 20 days apart, received 3 courses of infusions.

Treatment:

Drug: 99Tc-MDP(99Technetium-Methylenediphosphonate Injection)