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

Polymyalgia Rheumatica Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00982332
• Other study ID #: POLYMYALGIA1
• Status: Recruiting
• Phase: N/A
• First received: September 15, 2009
• Last updated: July 18, 2010
• Start date: March 2010
• Est. completion date: March 2012

Study information

• Verified date: July 2010
• Source: Bnai Zion Medical Center
• Contact: Gleb Slobodin, MD
• Phone: 972-506267284
• Email: gleb.slobodin[@]b-zion.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• clinical diagnosis of polymyalgia rheumatica

Exclusion Criteria:

• decompensated diabetes mellitus

• decompensated arterial hypertension

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Giant Cell Arteritis
• Polymyalgia Rheumatica

Intervention

Drug:
• Betamethasone
betamethasone dipropionate 20 mg + betamethasone sodium phosphate 8 md as a single intramuscular injection
• isotonic sodium chloride solution (placebo)
4 ml intramuscular

Locations

Country	Name	City	State
Israel	Bnai Zion Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a total dose of glucocorticoids used in the course of the disease		12 months	No