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

Phase 3

Terminated

• Conditions: Prosthesis Loosening
• Interventions: Drug: placebo; Drug: risedronate

• Registration Number: NCT02744482
• Lead Sponsor: University Hospital, Limoges

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-13
• Study First Submitted QC: 2016-04-19
• Study First Posted: 2016-04-20
• Study Start: 2016-05
• Primary Completion: 2018-03-22
• Study Completion: 2018-03-22
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-15
• Last Update Posted: 2018-10-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Patients take an oral tablet of Placebo, 2 consecutive days per month during 18 months.
Risedronate	risedronate	Patients take an oral tablet of Risedronate 75 mg, 2 consecutive days per month during 18 months.

Primary Outcome Measures

Name	Time	Method
Pain measurement	18, months	Measurement of pain by means of numerical rating scale.

Secondary Outcome Measures

Name	Time	Method
Pain measurement at rest	6 months, 12 months, 18, months, 24 moths	Measurement of pain by means of numerical rating scale
Pain measurement at walk	6 months, 12 months, 18, months, 24 moths	Measurement of pain by means of numerical rating scale

Trial Locations

Locations (1)

CHU Limoges; 🇫🇷 Limoges, France