Efficacy of Risedronate in Patients With Painful Periprosthetic Resorption of the Hip Prothesis

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Risedronate in Patients With Painful Periprosthetic Resorption of the Hip Prothesis Double-blind Randomized Study Versus Placebo

Conditions
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Prosthesis Loosening

Intervention / Treatment
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* Drug: risedronate
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects, 18 years of age or older. 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 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. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Risedronate<br>Patients take an oral tablet of Risedronate 75 mg, 2 consecutive days per month during 18 months. | Drug: risedronate<br>* risedrante tablet (75 mg)<br>|
| Placebo Comparator: Placebo<br>Patients take an oral tablet of Placebo, 2 consecutive days per month during 18 months. | Drug: placebo<br>* risedrante placebo tablet (75 mg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measurement | Measurement of pain by means of numerical rating scale. | 18, months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measurement at walk | Measurement of pain by means of numerical rating scale | 6 months, 12 months, 18, months, 24 moths | 
| Pain measurement at rest | Measurement of pain by means of numerical rating scale | 6 months, 12 months, 18, months, 24 moths |