Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance -
15 februari 2019 bijgewerkt door: Takeda
Sodium Risedronate 17.5 mg Tablets Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) - 48-week Surveillance -
The purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets administered once daily (one tablet per dose) in patients with osseous Paget's disease for 48 weeks from baseline in daily medical practice.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This special drug use surveillance was designed to evaluate the safety and efficacy of sodium risedronate tablets 17.5 mg administered once daily (one tablet per dose) in patients with osseous Paget's disease in daily medical practice.
The usual dosage for adults is 17.5 mg of sodium risedronate administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. For at least 30 minutes after administration, participants should avoid lying in a supine position and taking food, drink (except for water) or other oral drugs.
Studietype
Observationeel
Inschrijving (Werkelijk)
315
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
-
Osaka, Japan
-
Tokyo, Japan
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
Osseous Paget's disease
Beschrijving
Inclusion Criteria:
- Osseous Paget's disease patients treated with sodium risedronate tablets 17.5 mg
Exclusion Criteria:
-
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
17.5 mg of sodium risedronate
17.5 mg of sodium risedronate is administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks.
|
Sodium risedronate tablets
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Percentage of Participants Who Had One or More Adverse Drug Reactions
Tijdsspanne: Up to 48 weeks
|
Adverse drug reaction refers to adverse events related to administered drug.
|
Up to 48 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Percentage of Changes From Baseline in Excess Serum Alkaline Phosphatase (ALP) Level at Final Assessment Point
Tijdsspanne: Baseline and final assessment point (Up to 48 weeks)
|
Percentage of changes from baseline in excess serum ALP level at final assessment point (up to 48 weeks) was reported.
|
Baseline and final assessment point (Up to 48 weeks)
|
|
Percentage of Changes From Baseline in Serum ALP Level at Final Assessment Point
Tijdsspanne: Baseline and final assessment point (Up to 48 weeks)
|
Percentage of changes from baseline in serum ALP level at final assessment point (up to 48 weeks) was reported.
|
Baseline and final assessment point (Up to 48 weeks)
|
|
Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point
Tijdsspanne: Baseline and final assessment point (Up to 48 weeks)
|
Investigators marked severity of pain with a 4-point scale ranging from "None" to "Very Severe" (None, Mild, Severe, Very Severe) at baseline and the final assessment point.
This scale was specified on the protocol of this observational study.
The reported data were number of participants stratified by comparison of pain severity between baseline and final assessment point described as "None (at baseline) to Severe (at final assessment point)".
|
Baseline and final assessment point (Up to 48 weeks)
|
|
Number of Participants Stratified by Assessment of Image Findings of Bone Morphogenic Abnormalities at Final Assessment Point Compared With Baseline
Tijdsspanne: Baseline and final assessment point (Up to 48 weeks)
|
Investigator marked assessment of image findings of bone morphogenic abnormalities at final assessment point compared with baseline as follows; "improved", "unchanged", "worsened".
The reported data were the number of participants stratified by assessment of image findings at final assessment point.
|
Baseline and final assessment point (Up to 48 weeks)
|
|
Number of Participants Stratified by Assessment of Image Findings of Trabecular Bone Structural Abnormalities at Final Assessment Point Compared With Baseline
Tijdsspanne: Baseline and final assessment point (Up to 48 weeks)
|
Investigator marked assessment of image findings of trabecular bone structural abnormalities at final assessment point compared with baseline as follows; "improved", "unchanged", "worsened".
The reported data were the number of participants stratified by assessment of image findings at final assessment point.
|
Baseline and final assessment point (Up to 48 weeks)
|
|
Number of Participants Stratified by Assessment of Image Findings of Other Abnormalities at Final Assessment Point Compared With Baseline
Tijdsspanne: Baseline and final assessment point (Up to 48 weeks)
|
Other Abnormalities refer to bone abnormal findings excluding bone morphogenic abnormalities and trabecular bone structural abnormalities (see Outcome Measure 5 and 6).
Investigator marked assessment of image findings of other abnormalities at final assessment point compared with baseline as follows; "improved", "unchanged", "worsened".
The reported data were the number of participants stratified by assessment of image findings at final assessment point.
|
Baseline and final assessment point (Up to 48 weeks)
|
|
Percentage of Changes From Baseline in Urinary Type 1 Collagen Cross-Linked N-telopeptide (Urinary NTX) Level at Final Assessment Point
Tijdsspanne: Baseline and final assessment point (Up to 48 weeks)
|
Percentage of changes from baseline in urinary NTX level at final assessment point (up to 48 weeks) was reported.
Urinary NTX is one of bone metabolism markers.
|
Baseline and final assessment point (Up to 48 weeks)
|
|
Percentage of Changes From Baseline in Urinary Deoxypyridinoline (Urinary DPD) Level at Final Assessment Point
Tijdsspanne: Baseline and final assessment point (Up to 48 weeks)
|
Percentage of changes from baseline in urinary DPD level at final assessment point (up to 48 weeks) was reported.
Urinary DPD is one of bone metabolism markers.
|
Baseline and final assessment point (Up to 48 weeks)
|
|
Percentage of Changes From Baseline in Serum Bone Alkaline Phosphatase (Serum BAP) Level at Final Assessment Point
Tijdsspanne: Baseline and final assessment point (Up to 48 weeks)
|
Percentage of changes from baseline in serum BAP level at final assessment point (up to 48 weeks) was reported.
Serum BAP is one of bone metabolism markers.
|
Baseline and final assessment point (Up to 48 weeks)
|
|
Percentage of Participants Stratified by Treatment Compliance (Medicine Adherence) During Treatment Period
Tijdsspanne: Up to 48 weeks
|
Treatment compliance of this outcome measure refers to the percentage of participants who correctly follow medication.
The reported data are percentage of participants in the classification including 4 specific degrees of treatment compliance; 90 % or more; 67 % or more and <90 %; 25 % or more and <67 %; less than 25 % or "unknown".
|
Up to 48 weeks
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 augustus 2008
Primaire voltooiing (Werkelijk)
24 oktober 2017
Studie voltooiing (Werkelijk)
24 oktober 2017
Studieregistratiedata
Eerst ingediend
3 april 2014
Eerst ingediend dat voldeed aan de QC-criteria
7 april 2014
Eerst geplaatst (Schatting)
8 april 2014
Updates van studierecords
Laatste update geplaatst (Werkelijk)
3 juni 2019
Laatste update ingediend die voldeed aan QC-criteria
15 februari 2019
Laatst geverifieerd
1 februari 2019
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 067-211
- JapicCTI-142480 (Register-ID: JapicCTI)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .