- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02744482
Efficacy of Risedronate in Patients With Painful Periprosthetic Resorption of the Hip Prothesis (PTH)
Efficacy of Risedronate in Patients With Painful Periprosthetic Resorption of the Hip Prothesis Double-blind Randomized Study Versus Placebo
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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-
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Limoges, Frankrig, 87100
- CHU Limoges
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Risedronate
Patients take an oral tablet of Risedronate 75 mg, 2 consecutive days per month during 18 months.
|
risedrante tablet (75 mg)
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Placebo komparator: Placebo
Patients take an oral tablet of Placebo, 2 consecutive days per month during 18 months.
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risedrante placebo tablet (75 mg)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pain measurement
Tidsramme: 18, months
|
Measurement of pain by means of numerical rating scale.
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18, months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pain measurement at walk
Tidsramme: 6 months, 12 months, 18, months, 24 moths
|
Measurement of pain by means of numerical rating scale
|
6 months, 12 months, 18, months, 24 moths
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Pain measurement at rest
Tidsramme: 6 months, 12 months, 18, months, 24 moths
|
Measurement of pain by means of numerical rating scale
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6 months, 12 months, 18, months, 24 moths
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- I14005
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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University of OklahomaNational Center for Research Resources (NCRR)AfsluttetDiabetes mellitus, voksendebutForenede Stater