Efficacy of Risedronate in Patients With Painful Periprosthetic Resorption of the Hip Prothesis
NCT ID: NCT02744482
Last Updated: 2018-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
3 participants
INTERVENTIONAL
2016-05-31
2018-03-22
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Risedronate
Patients take an oral tablet of Risedronate 75 mg, 2 consecutive days per month during 18 months.
risedronate
risedrante tablet (75 mg)
Placebo
Patients take an oral tablet of Placebo, 2 consecutive days per month during 18 months.
placebo
risedrante placebo tablet (75 mg)
Interventions
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risedronate
risedrante tablet (75 mg)
placebo
risedrante placebo tablet (75 mg)
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
* Subjects with cemented or not cemented total hip prothesis (for primitive or secondary coxarthrosis)
* Painful aseptic loosening
* Subject has pain 4 or greater on a 10 point Visual Pain Rating scale
* For subject woman of reproductive age, they must use reliable method(s) of contraception and/or abstinence, for the duration of therapeutic product exposure.
Exclusion Criteria
. 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.
* Subjects with Hypocalcemia
* Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
* Subjects with severe kidney failure ( creatinine \< 30 ml/min)).
* Subjects participation in another research study
* Subjects with previous osteonecrosis of the jaw
18 Years
ALL
No
Sponsors
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University Hospital, Limoges
OTHER
Responsible Party
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Locations
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CHU Limoges
Limoges, , France
Countries
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Other Identifiers
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I14005
Identifier Type: -
Identifier Source: org_study_id
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