Status and phase
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About
This is an experimental study, prospective, comparative. This clinical trial is randomized and double-blind, Residronate versus placebo.
The study aims to demonstrate the effectiveness of risedronate in pain management, after 18 month of traitment, in patients undergoing aseptic joint prosthesis loosening. 2 groups were compared with a 1: 1 ratio. The first group receives active drug (risedronate 75mg) and the second a placebo.
Patients are treated during 18 months: 1 tablet residronate/placebo per os two consecutive days each month.
Evaluations are planned evry 6 months.
Enrollment
Sex
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Volunteers
Inclusion criteria
Exclusion criteria
Subjects with septic loosening of hip prosthesis
. Subjects with bilateral disease
Subjects with implant mobility associated with pre-operative and intraoperative loosening
Subjects under anti-osteoporotic treatment
Subjects having stopped a biphosphonate traetment for less than one year
Subjects with known allergy or sensitivity to any of the components in the study medication.
Primary purpose
Allocation
Interventional model
Masking
3 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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