Trial record 8 of 18 for:    Open Studies | "Giant Cell Arteritis"

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
Information provided by:
Bnai Zion Medical Center Identifier:
First received: September 15, 2009
Last updated: July 18, 2010
Last verified: July 2010
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:

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


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • clinical diagnosis of polymyalgia rheumatica

Exclusion Criteria:

  • decompensated diabetes mellitus
  • decompensated arterial hypertension
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00982332

Contact: Gleb Slobodin, MD 972-506267284

Bnai Zion Medical Center Recruiting
Haifa, Israel, 38041
Contact: Gleb Slobodin, MD    972-506267284   
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 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:
Giant Cell Arteritis
Polymyalgia Rheumatica
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Connective Tissue Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Rheumatic Diseases
Skin Diseases
Skin Diseases, Vascular
Vascular Diseases
Vasculitis, Central Nervous System
Betamethasone Valerate
Betamethasone benzoate
Betamethasone sodium phosphate
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on May 24, 2016