NCT02744482

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2018

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

1.9 years

First QC Date

April 13, 2016

Last Update Submit

October 15, 2018

Conditions

Prosthesis Loosening

Outcome Measures

Primary Outcomes (1)

  • Pain measurement

    Measurement of pain by means of numerical rating scale.

    18, months

Secondary Outcomes (2)

  • Pain measurement at walk

    6 months, 12 months, 18, months, 24 moths

  • Pain measurement at rest

    6 months, 12 months, 18, months, 24 moths

Study Arms (2)

Risedronate

EXPERIMENTAL

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

Drug: risedronate

Placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

risedronateDRUG

risedrante tablet (75 mg)

Risedronate
placeboDRUG

risedrante placebo tablet (75 mg)

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Limoges

Limoges, 87100, France

Location

MeSH Terms

Conditions

Prosthesis Failure

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2016

First Posted

April 20, 2016

Study Start

May 1, 2016

Primary Completion

March 22, 2018

Study Completion

March 22, 2018

Last Updated

October 17, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)