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

Sponsor
Bnai Zion Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00982332
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
24
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
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
Study Start Date :
Mar 1, 2010
Anticipated Primary Completion Date :
Sep 1, 2011
Anticipated Study Completion Date :
Mar 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. a total dose of glucocorticoids used in the course of the disease [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • clinical diagnosis of polymyalgia rheumatica
    Exclusion Criteria:

    • decompensated diabetes mellitus

    • decompensated arterial hypertension

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bnai Zion Medical Center Haifa Israel 38041

    Sponsors and Collaborators

    • Bnai Zion Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00982332
    Other Study ID Numbers:
    • POLYMYALGIA1
    First Posted:
    Sep 23, 2009
    Last Update Posted:
    Jul 20, 2010
    Last Verified:
    Jul 1, 2010
    Keywords provided by , ,
    polymyalgia rheumatica
    Additional relevant MeSH terms:
    Polymyalgia Rheumatica
    Giant Cell Arteritis
    Betamethasone
    Betamethasone dipropionate, betamethasone sodium phosphate drug combination

    Study Results

    No Results Posted as of Jul 20, 2010