36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Sodium Risedronate 75 mg Tablets
18 juli 2019 uppdaterad av: Takeda
36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Benet 75 mg Tablets
The purpose of this survey is to evaluate the effectiveness (endpoints: frequency of bone fractures, percent change in bone density, etc.) and safety of administration of sodium risedronate tablets 75 mg for 36 months in osteoporosis patients in daily medical practice.
Studieöversikt
Detaljerad beskrivning
This special drug use surveillance was designed to evaluate the effectiveness (endpoints: frequency of bone fractures, percent change from baseline in bone density, etc.) and safety of sodium risedronate 75 mg tablets in osteoporosis patients in daily medical practice.
The usual dosage for adult is 75 mg of sodium risedronate administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking.
Studietyp
Observationell
Inskrivning (Faktisk)
579
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
50 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Osteoporosis
Beskrivning
Inclusion Criteria:
Osteoporosis patients who meet all the following criteria:
- Patients with 1 to 4 confirmed vertebral body fractures in the T4-L4 region by thoracic and lumbar spine X-ray examination at screening (within 3 months before the start of administration of sodium risedronate 75 mg tablets)
- Male and postmenopausal female patients aged 50 years or older
- Ambulatory outpatients
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 |
|---|---|
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Sodium Risedronate 75 mg
75 mg of sodium risedronate is administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking.
Participants receive sodium risedronate 75 mg as part of routine medical care.
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Sodium risedronate tablets
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures
Tidsram: From baseline up to Month 36
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The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.
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From baseline up to Month 36
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Cumulative Percentage of Participants With Non-Vertebral Body Fractures
Tidsram: From baseline up to Month 36
|
The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.
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From baseline up to Month 36
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Cumulative Percentage of Participants With Femur Fractures
Tidsram: From baseline up to Month 36
|
The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.
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From baseline up to Month 36
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Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment (up to Month 36)
Tidsram: Baseline and final assessment (up to Month 36)
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BMD was measured by dual-energy X-ray absorptiometry.
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Baseline and final assessment (up to Month 36)
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Percent Change From Baseline in Femur Neck BMD at Final Assessment (up to Month 36)
Tidsram: Baseline and final assessment (up to Month 36)
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BMD was measured by dual-energy X-ray absorptiometry.
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Baseline and final assessment (up to Month 36)
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Percent Change From Baseline in Total Proximal Femur BMD at Final Assessment (up to Month 36)
Tidsram: Baseline and final assessment (up to Month 36)
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BMD was measured by dual-energy X-ray absorptiometry.
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Baseline and final assessment (up to Month 36)
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Percent Change From Baseline in Radius BMD at Final Assessment (up to Month 36)
Tidsram: Baseline and final assessment (up to Month 36)
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BMD was measured by dual-energy X-ray absorptiometry.
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Baseline and final assessment (up to Month 36)
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Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)
Tidsram: Baseline and final assessment (up to Month 36)
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Baseline and final assessment (up to Month 36)
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Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment (up to Month 36)
Tidsram: Baseline and final assessment (up to Month 36)
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Baseline and final assessment (up to Month 36)
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Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment (up to Month 36)
Tidsram: Baseline and final assessment (up to Month 36)
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Baseline and final assessment (up to Month 36)
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Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment (up to Month 36)
Tidsram: Baseline and final assessment (up to Month 36)
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Baseline and final assessment (up to Month 36)
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Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)
Tidsram: Baseline and final assessment (up to Month 36)
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Baseline and final assessment (up to Month 36)
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Change From Baseline in Height at Final Assessment (up to Month 36)
Tidsram: Baseline and final assessment (up to Month 36)
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Baseline and final assessment (up to Month 36)
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Number of Participants Who Had Lumbar Backache at Final Assessment (up to Month 36)
Tidsram: Final assessment (up to Month 36)
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Final assessment (up to Month 36)
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Number of Participants Who Had One or More Adverse Drug Reactions
Tidsram: Up to Month 36
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Adverse drug reaction refers to adverse events related to the administered drug.
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Up to Month 36
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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)
13 maj 2013
Primärt slutförande (Faktisk)
30 april 2018
Avslutad studie (Faktisk)
30 april 2018
Studieregistreringsdatum
Först inskickad
3 april 2014
Först inskickad som uppfyllde QC-kriterierna
3 april 2014
Första postat (Uppskatta)
8 april 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 juli 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 juli 2019
Senast verifierad
1 juli 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Metaboliska sjukdomar
- Sår och skador
- Muskuloskeletala sjukdomar
- Skelettsjukdomar
- Skelettsjukdomar, metaboliska
- Frakturer, ben
- Osteoporos
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Membrantransportmodulatorer
- Bendensitetsbevarande medel
- Kalciumreglerande hormoner och medel
- Kalciumkanalblockerare
- Risedronsyra
Andra studie-ID-nummer
- 178-002
- JapicCTI-142479 (Registeridentifierare: JapicCTI)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com
for details).
To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias.
Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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