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

Not Applicable

• Conditions: Polymyalgia Rheumatica
• Interventions: Drug: Betamethasone; Drug: isotonic sodium chloride solution (placebo)

• Registration Number: NCT00982332
• Lead Sponsor: Bnai Zion Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-15
• Study First Submitted QC: 2009-09-22
• Study First Posted: 2009-09-23
• Study Start: 2010-03
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-18
• Last Update Posted: 2010-07-20
• Primary Completion: 2011-09
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• clinical diagnosis of polymyalgia rheumatica

Exclusion Criteria

• decompensated diabetes mellitus
• decompensated arterial hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
betamethasone	Betamethasone	patients treated with a single intramuscular injection of betamethasone
betamethasone	isotonic sodium chloride solution (placebo)	patients treated with a single intramuscular injection of betamethasone
isotonic sodium chloride solution	isotonic sodium chloride solution (placebo)	-

Primary Outcome Measures

Name	Time	Method
a total dose of glucocorticoids used in the course of the disease	12 months

Trial Locations

Locations (1)

Bnai Zion Medical Center; 🇮🇱 Haifa, Israel