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

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

NCT02744482

I14005

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

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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