An interventional study of Betamethasone and isotonic sodium chloride solution (placebo) in Polymyalgia Rheumatica, sponsored by Bnai Zion Medical Center. Status unknown at 1 site in Israel. Per ClinicalTrials.gov, last updated 2010-07-20.
Sponsored by Bnai Zion Medical Center · Not applicable, Interventional, and Treatment
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.
138 studies on the registry are indexed under Polymyalgia Rheumatica; 29 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 70 interventional studies indexed under Polymyalgia Rheumatica.
Browse Polymyalgia Rheumatica studies →Bnai Zion Medical Center is the lead sponsor of 104 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
patients treated with a single intramuscular injection of betamethasone
Drug: Betamethasone · Drug: isotonic sodium chloride solution (placebo)
Drug: isotonic sodium chloride solution (placebo)
betamethasone dipropionate 20 mg + betamethasone sodium phosphate 8 md as a single intramuscular injection
Also known as: diprospan injection
4 ml intramuscular
a total dose of glucocorticoids used in the course of the disease
Time frame: 12 months
This study is status unknown, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Betamethasone