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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:
Sponsor: University Hospital, Limoges

Current Primary Outcome: Pain measurement [ Time Frame: 18, months ]

Measurement of pain by means of numerical rating scale.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain measurement at walk [ Time Frame: 6 months, 12 months, 18, months, 24 moths ]
    Measurement of pain by means of numerical rating scale
  • Pain measurement at rest [ Time Frame: 6 months, 12 months, 18, months, 24 moths ]
    Measurement of pain by means of numerical rating scale


Original Secondary Outcome: Same as current

Information By: University Hospital, Limoges

Dates:
Date Received: April 13, 2016
Date Started: May 2016
Date Completion: July 2020
Last Updated: August 11, 2016
Last Verified: August 2016