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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Bnai Zion Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Bnai Zion Medical Center
ClinicalTrials.gov Identifier:
NCT00982332
First received: September 15, 2009
Last updated: July 18, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention
Polymyalgia Rheumatica
 Drug: Betamethasone
Drug: isotonic sodium chloride solution (placebo)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Micro-pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bnai Zion Medical Center:

Primary Outcome Measures:
  • a total dose of glucocorticoids used in the course of the disease [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: betamethasone
patients treated with a single intramuscular injection of betamethasone
 Drug: Betamethasone
betamethasone dipropionate 20 mg + betamethasone sodium phosphate 8 md as a single intramuscular injection
Other Name: diprospan injection
Drug: isotonic sodium chloride solution (placebo)
4 ml intramuscular
Placebo Comparator: isotonic sodium chloride solution Drug: isotonic sodium chloride solution (placebo)
4 ml intramuscular

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of polymyalgia rheumatica

Exclusion Criteria:

  • decompensated diabetes mellitus
  • decompensated arterial hypertension
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00982332

Contacts
Contact: Gleb Slobodin, MD 972-506267284 gleb.slobodin@b-zion.org.il

Locations
Israel
Bnai Zion Medical Center Recruiting
Haifa, Israel, 38041
Contact: Gleb Slobodin, MD     972-506267284     gleb.slobodin@b-zion.org.il    
Sub-Investigator: Doron Rimar, MD            
Principal Investigator: Gleb Slobodin, MD            
Sub-Investigator: Mona Elias, MD            
Sub-Investigator: Michael Rozenbaum, MD            
Sub-Investigator: Nina Boulman, MD            
Sub-Investigator: Itzhak Rosner, MD            
Sponsors and Collaborators
Bnai Zion Medical Center
  More Information

No publications provided

Responsible Party: Gleb Slobodin MD, Bnai Zion MC
ClinicalTrials.gov Identifier: NCT00982332     History of Changes
Other Study ID Numbers: POLYMYALGIA1
Study First Received: September 15, 2009
Last Updated: July 18, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Bnai Zion Medical Center:
polymyalgia rheumatica

Additional relevant MeSH terms:
Polymyalgia Rheumatica
Giant Cell Arteritis
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Arteritis
Vascular Diseases
Cardiovascular Diseases
 Vasculitis
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on May 16, 2013