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Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance -

15. februar 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

315

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Japan
      • Osaka, Japan
      • Tokyo, Japan

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Osseous Paget's disease

Beskrivelse

Inclusion Criteria:

  • Osseous Paget's disease patients treated with sodium risedronate tablets 17.5 mg

Exclusion Criteria:

-

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Medicin: Sodium risedronate
Sodium risedronate tablets
Andre navne:
  • Benet 17.5mg Tablets
  • Actonel 17.5mg Tablets

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
Up to 48 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
Baseline and final assessment point (Up to 48 weeks)
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.
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
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)".
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
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.
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
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.
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
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.
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
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.
Baseline and final assessment point (Up to 48 weeks)
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.
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
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.
Baseline and final assessment point (Up to 48 weeks)
Percentage of Participants Stratified by Treatment Compliance (Medicine Adherence) During Treatment Period
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Takeda

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2008

Primær færdiggørelse (Faktiske)

24. oktober 2017

Studieafslutning (Faktiske)

24. oktober 2017

Datoer for studieregistrering

Først indsendt

3. april 2014

Først indsendt, der opfyldte QC-kriterier

7. april 2014

Først opslået (Skøn)

8. april 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. februar 2019

Sidst verificeret

1. februar 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 067-211
  • JapicCTI-142480 (Registry Identifier: JapicCTI)

Plan for individuelle deltagerdata (IPD)

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INGEN

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Kliniske forsøg med Sodium risedronate

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