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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. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Bnai Zion Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00982332
First Posted: September 23, 2009
Last Update Posted: July 20, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bnai Zion Medical Center
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of polymyalgia rheumatica

Exclusion Criteria:

  • decompensated diabetes mellitus
  • decompensated arterial hypertension
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Gleb Slobodin MD, Bnai Zion MC
ClinicalTrials.gov Identifier: NCT00982332     History of Changes
Other Study ID Numbers: POLYMYALGIA1
First Submitted: September 15, 2009
First Posted: September 23, 2009
Last Update Posted: July 20, 2010
Last Verified: July 2010

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
Vascular Diseases
Cardiovascular Diseases
Arteritis
Vasculitis
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs