NCT00982332

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Bnai Zion Medical Center · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Polymyalgia Rheumatica

Interventions

Type	Name	Description
DRUG	Betamethasone	betamethasone dipropionate 20 mg + betamethasone sodium phosphate 8 md as a single intramuscular injection
DRUG	isotonic sodium chloride solution (placebo)	4 ml intramuscular

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-09-01
• Completion: 2012-03-01
• First posted: 2009-09-23
• Last updated: 2010-07-20

Locations

1 site across 1 country: Israel