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

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

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.

Study Overview

• Status: Terminated
• Conditions: Prosthesis Loosening
• Intervention / Treatment: Drug: risedronate; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87100
    • CHU Limoges

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): March 22, 2018
• Study Completion (Actual): March 22, 2018

Study Registration Dates

• First Submitted: April 13, 2016
• First Submitted That Met QC Criteria: April 19, 2016
• First Posted (Estimate): April 20, 2016

Study Record Updates

• Last Update Posted (Actual): October 17, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Prosthesis Failure; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Risedronic Acid
• Other Study ID Numbers: I14005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No