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

Primary Purpose

Prosthesis Loosening

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
risedronate
placebo
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prosthesis Loosening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Limoges

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Risedronate

Placebo

Arm Description

Patients take an oral tablet of Risedronate 75 mg, 2 consecutive days per month during 18 months.

Patients take an oral tablet of Placebo, 2 consecutive days per month during 18 months.

Outcomes

Primary Outcome Measures

Pain measurement
Measurement of pain by means of numerical rating scale.

Secondary Outcome Measures

Pain measurement at walk
Measurement of pain by means of numerical rating scale
Pain measurement at rest
Measurement of pain by means of numerical rating scale

Full Information

First Posted
April 13, 2016
Last Updated
October 15, 2018
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT02744482
Brief Title
Efficacy of Risedronate in Patients With Painful Periprosthetic Resorption of the Hip Prothesis
Acronym
PTH
Official Title
Efficacy of Risedronate in Patients With Painful Periprosthetic Resorption of the Hip Prothesis Double-blind Randomized Study Versus Placebo
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
lack of patients
Study Start Date
May 2016 (undefined)
Primary Completion Date
March 22, 2018 (Actual)
Study Completion Date
March 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthesis Loosening

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Risedronate
Arm Type
Experimental
Arm Description
Patients take an oral tablet of Risedronate 75 mg, 2 consecutive days per month during 18 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients take an oral tablet of Placebo, 2 consecutive days per month during 18 months.
Intervention Type
Drug
Intervention Name(s)
risedronate
Intervention Description
risedrante tablet (75 mg)
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
risedrante placebo tablet (75 mg)
Primary Outcome Measure Information:
Title
Pain measurement
Description
Measurement of pain by means of numerical rating scale.
Time Frame
18, months
Secondary Outcome Measure Information:
Title
Pain measurement at walk
Description
Measurement of pain by means of numerical rating scale
Time Frame
6 months, 12 months, 18, months, 24 moths
Title
Pain measurement at rest
Description
Measurement of pain by means of numerical rating scale
Time Frame
6 months, 12 months, 18, months, 24 moths

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CHU Limoges
City
Limoges
ZIP/Postal Code
87100
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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