Efficacy of Micro-Pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica

Bnai Zion Medical Center

Status: Unknown

Conditions: Polymyalgia Rheumatica

Treatments: Drug: isotonic sodium chloride solution (placebo); Drug: Betamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT00982332

POLYMYALGIA1

Details and patient eligibility

About

The study will examine the efficacy of a single intramuscular injection of betamethasone dipropionate/betamethasone sodium phosphate at the dose of 20mg/8mg (injection volume 4 ml) as an induction therapy in patients with polymyalgia rheumatica. Twenty patients will be randomized to receive an injection of betamethasone or placebo (isotonic NaCl solution) immediately after diagnosis. Both groups will receive the standard-of-care steroid therapy, starting from 10 mg of prednisone every day (qd), tapered down by 2.5 mg monthly if the disease is not active (scheduled monthly follow-ups by a rheumatologist). Primary outcome measures: the total cumulative dose of glucocorticosteroids and disease duration.

Enrollment: 20 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinical diagnosis of polymyalgia rheumatica

Exclusion criteria

• decompensated diabetes mellitus
• decompensated arterial hypertension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

betamethasone

Active Comparator group

Description:

patients treated with a single intramuscular injection of betamethasone

Treatment:

Drug: Betamethasone

Drug: isotonic sodium chloride solution (placebo)

isotonic sodium chloride solution

Placebo Comparator group

Treatment:

Drug: isotonic sodium chloride solution (placebo)