Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance -
15 februari 2019 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
315
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Osaka, Japan
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Tokyo, Japan
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
Osseous Paget's disease
Beskrivning
Inclusion Criteria:
- Osseous Paget's disease patients treated with sodium risedronate tablets 17.5 mg
Exclusion Criteria:
-
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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.
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Sodium risedronate tablets
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Percentage of Participants Who Had One or More Adverse Drug Reactions
Tidsram: Up to 48 weeks
|
Adverse drug reaction refers to adverse events related to administered drug.
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Up to 48 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Changes From Baseline in Excess Serum Alkaline Phosphatase (ALP) Level at Final Assessment Point
Tidsram: 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)
|
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Percentage of Changes From Baseline in Serum ALP Level at Final Assessment Point
Tidsram: 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)
|
|
Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
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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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
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Percentage of Participants Stratified by Treatment Compliance (Medicine Adherence) During Treatment Period
Tidsram: 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".
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Up to 48 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 augusti 2008
Primärt slutförande (Faktisk)
24 oktober 2017
Avslutad studie (Faktisk)
24 oktober 2017
Studieregistreringsdatum
Först inskickad
3 april 2014
Först inskickad som uppfyllde QC-kriterierna
7 april 2014
Första postat (Uppskatta)
8 april 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 juni 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 februari 2019
Senast verifierad
1 februari 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 067-211
- JapicCTI-142480 (Registeridentifierare: JapicCTI)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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