Efficacy of Micro-Pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica
Information source: Bnai Zion Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polymyalgia Rheumatica
Intervention: Betamethasone (Drug); isotonic sodium chloride solution (placebo) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Bnai Zion Medical Center Overall contact:
Gleb Slobodin, MD, Phone: 972-506267284, Email: gleb.slobodin@b-zion.org.il
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.
Clinical Details
Official title: Efficacy of Micro-pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: a total dose of glucocorticoids used in the course of the disease
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- clinical diagnosis of polymyalgia rheumatica
Exclusion Criteria:
- decompensated diabetes mellitus
- decompensated arterial hypertension
Locations and Contacts
Gleb Slobodin, MD, Phone: 972-506267284, Email: gleb.slobodin@b-zion.org.il
Bnai Zion Medical Center, Haifa 38041, Israel; Recruiting
Gleb Slobodin, MD, Phone: 972-506267284, Email: gleb.slobodin@b-zion.org.il
Doron Rimar, MD, Sub-Investigator
Gleb Slobodin, MD, Principal Investigator
Mona Elias, MD, Sub-Investigator
Michael Rozenbaum, MD, Sub-Investigator
Nina Boulman, MD, Sub-Investigator
Itzhak Rosner, MD, Sub-Investigator
Additional Information
Starting date: March 2010
Last updated: July 18, 2010
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