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

Primary Purpose

Polymyalgia Rheumatica

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Betamethasone
isotonic sodium chloride solution (placebo)
Sponsored by
Bnai Zion Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polymyalgia Rheumatica focused on measuring polymyalgia rheumatica

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • clinical diagnosis of polymyalgia rheumatica

Exclusion Criteria:

  • decompensated diabetes mellitus
  • decompensated arterial hypertension

Sites / Locations

  • Bnai Zion Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

betamethasone

isotonic sodium chloride solution

Arm Description

patients treated with a single intramuscular injection of betamethasone

Outcomes

Primary Outcome Measures

a total dose of glucocorticoids used in the course of the disease

Secondary Outcome Measures

Full Information

First Posted
September 15, 2009
Last Updated
July 18, 2010
Sponsor
Bnai Zion Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00982332
Brief Title
Efficacy of Micro-Pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica
Official Title
Efficacy of Micro-pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Bnai Zion Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polymyalgia Rheumatica
Keywords
polymyalgia rheumatica

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
betamethasone
Arm Type
Active Comparator
Arm Description
patients treated with a single intramuscular injection of betamethasone
Arm Title
isotonic sodium chloride solution
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Betamethasone
Other Intervention Name(s)
diprospan injection
Intervention Description
betamethasone dipropionate 20 mg + betamethasone sodium phosphate 8 md as a single intramuscular injection
Intervention Type
Drug
Intervention Name(s)
isotonic sodium chloride solution (placebo)
Intervention Description
4 ml intramuscular
Primary Outcome Measure Information:
Title
a total dose of glucocorticoids used in the course of the disease
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: clinical diagnosis of polymyalgia rheumatica Exclusion Criteria: decompensated diabetes mellitus decompensated arterial hypertension
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gleb Slobodin, MD
Phone
972-506267284
Email
gleb.slobodin@b-zion.org.il
Facility Information:
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
38041
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gleb Slobodin, MD
Phone
972-506267284
Email
gleb.slobodin@b-zion.org.il
First Name & Middle Initial & Last Name & Degree
Doron Rimar, MD
First Name & Middle Initial & Last Name & Degree
Gleb Slobodin, MD
First Name & Middle Initial & Last Name & Degree
Mona Elias, MD
First Name & Middle Initial & Last Name & Degree
Michael Rozenbaum, MD
First Name & Middle Initial & Last Name & Degree
Nina Boulman, MD
First Name & Middle Initial & Last Name & Degree
Itzhak Rosner, MD

12. IPD Sharing Statement

Learn more about this trial

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

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