Efficacy of Risedronate in Patients With Painful Periprosthetic Resorption of the Hip Prothesis (NCT02744482) | Clinical Trial Compass
TerminatedPhase 3
Efficacy of Risedronate in Patients With Painful Periprosthetic Resorption of the Hip Prothesis
Stopped: lack of patients
France3 participantsStarted 2016-05
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.