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

Prosthesis Loosening Clinical Trial

— PTH  

Official title:

Efficacy of Risedronate in Patients With Painful Periprosthetic Resorption of the Hip Prothesis Double-blind Randomized Study Versus Placebo

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02744482
• Other study ID #: I14005
• Status: Terminated
• Phase: Phase 3
• Start date: May 2016
• Est. completion date: March 22, 2018

Study information

• Verified date: October 2018
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 22, 2018
• Est. primary completion date: March 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prosthesis Failure
• Prosthesis Loosening

Intervention

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

Locations

Country	Name	City	State
France	CHU Limoges	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain measurement	Measurement of pain by means of numerical rating scale.	18, months
Secondary	Pain measurement at walk	Measurement of pain by means of numerical rating scale	6 months, 12 months, 18, months, 24 moths
Secondary	Pain measurement at rest	Measurement of pain by means of numerical rating scale	6 months, 12 months, 18, months, 24 moths