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

• Status: Terminated
• Trial end date: 2018-03-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Limoges
• Treatments: Etidronic Acid; Risedronate Sodium; Risedronic Acid

Criteria

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