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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 22, 2018

Interventions

  • Drug: risedronate
    • risedrante tablet (75 mg)
  • Drug: placebo
    • risedrante placebo tablet (75 mg)

Arms, Groups and Cohorts

  • Experimental: Risedronate
    • Patients take an oral tablet of Risedronate 75 mg, 2 consecutive days per month during 18 months.
  • Placebo Comparator: Placebo
    • Patients take an oral tablet of Placebo, 2 consecutive days per month during 18 months.

Clinical Trial Outcome Measures

Primary Measures

  • Pain measurement
    • Time Frame: 18, months
    • Measurement of pain by means of numerical rating scale.

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Limoges
  • Provider of Information About this Clinical Study
    • Sponsor

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