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

U

University of Limoges (UL)

Status and phase

Terminated
Phase 3

Conditions

Prosthesis Loosening

Treatments

Drug: risedronate
Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

3 participants in 2 patient groups, including a placebo group

Risedronate
Experimental group
Description:
Patients take an oral tablet of Risedronate 75 mg, 2 consecutive days per month during 18 months.
Treatment:
Drug: risedronate
Placebo
Placebo Comparator group
Description:
Patients take an oral tablet of Placebo, 2 consecutive days per month during 18 months.
Treatment:
Drug: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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