Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance -
15. februar 2019 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Observasjonsmessig
Registrering (Faktiske)
315
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Osaka, Japan
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Tokyo, Japan
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Osseous Paget's disease
Beskrivelse
Inclusion Criteria:
- Osseous Paget's disease patients treated with sodium risedronate tablets 17.5 mg
Exclusion Criteria:
-
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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.
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Sodium risedronate tablets
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants Who Had One or More Adverse Drug Reactions
Tidsramme: Up to 48 weeks
|
Adverse drug reaction refers to adverse events related to administered drug.
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Up to 48 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Changes From Baseline in Excess Serum Alkaline Phosphatase (ALP) Level at Final Assessment Point
Tidsramme: 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.
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Baseline and final assessment point (Up to 48 weeks)
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Percentage of Changes From Baseline in Serum ALP Level at Final Assessment Point
Tidsramme: 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.
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Baseline and final assessment point (Up to 48 weeks)
|
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Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point
Tidsramme: 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)".
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Baseline and final assessment point (Up to 48 weeks)
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Number of Participants Stratified by Assessment of Image Findings of Bone Morphogenic Abnormalities at Final Assessment Point Compared With Baseline
Tidsramme: 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.
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Baseline and final assessment point (Up to 48 weeks)
|
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Number of Participants Stratified by Assessment of Image Findings of Trabecular Bone Structural Abnormalities at Final Assessment Point Compared With Baseline
Tidsramme: 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.
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Baseline and final assessment point (Up to 48 weeks)
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Number of Participants Stratified by Assessment of Image Findings of Other Abnormalities at Final Assessment Point Compared With Baseline
Tidsramme: 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.
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Baseline and final assessment point (Up to 48 weeks)
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Percentage of Changes From Baseline in Urinary Type 1 Collagen Cross-Linked N-telopeptide (Urinary NTX) Level at Final Assessment Point
Tidsramme: 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.
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Baseline and final assessment point (Up to 48 weeks)
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Percentage of Changes From Baseline in Urinary Deoxypyridinoline (Urinary DPD) Level at Final Assessment Point
Tidsramme: 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.
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Baseline and final assessment point (Up to 48 weeks)
|
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Percentage of Changes From Baseline in Serum Bone Alkaline Phosphatase (Serum BAP) Level at Final Assessment Point
Tidsramme: 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.
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Baseline and final assessment point (Up to 48 weeks)
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Percentage of Participants Stratified by Treatment Compliance (Medicine Adherence) During Treatment Period
Tidsramme: Up to 48 weeks
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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".
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Up to 48 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. august 2008
Primær fullføring (Faktiske)
24. oktober 2017
Studiet fullført (Faktiske)
24. oktober 2017
Datoer for studieregistrering
Først innsendt
3. april 2014
Først innsendt som oppfylte QC-kriteriene
7. april 2014
Først lagt ut (Anslag)
8. april 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. juni 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. februar 2019
Sist bekreftet
1. februar 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 067-211
- JapicCTI-142480 (Registeridentifikator: JapicCTI)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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