36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Sodium Risedronate 75 mg Tablets
18. juli 2019 oppdatert 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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
579
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Osaka, Japan
-
Tokyo, Japan
-
-
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
50 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Osteoporosis
Beskrivelse
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
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 |
|---|---|
|
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.
|
Sodium risedronate tablets
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures
Tidsramme: 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.
|
From baseline up to Month 36
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cumulative Percentage of Participants With Non-Vertebral Body Fractures
Tidsramme: 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.
|
From baseline up to Month 36
|
|
Cumulative Percentage of Participants With Femur Fractures
Tidsramme: 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.
|
From baseline up to Month 36
|
|
Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment (up to Month 36)
Tidsramme: Baseline and final assessment (up to Month 36)
|
BMD was measured by dual-energy X-ray absorptiometry.
|
Baseline and final assessment (up to Month 36)
|
|
Percent Change From Baseline in Femur Neck BMD at Final Assessment (up to Month 36)
Tidsramme: Baseline and final assessment (up to Month 36)
|
BMD was measured by dual-energy X-ray absorptiometry.
|
Baseline and final assessment (up to Month 36)
|
|
Percent Change From Baseline in Total Proximal Femur BMD at Final Assessment (up to Month 36)
Tidsramme: Baseline and final assessment (up to Month 36)
|
BMD was measured by dual-energy X-ray absorptiometry.
|
Baseline and final assessment (up to Month 36)
|
|
Percent Change From Baseline in Radius BMD at Final Assessment (up to Month 36)
Tidsramme: Baseline and final assessment (up to Month 36)
|
BMD was measured by dual-energy X-ray absorptiometry.
|
Baseline and final assessment (up to Month 36)
|
|
Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)
Tidsramme: Baseline and final assessment (up to Month 36)
|
Baseline and final assessment (up to Month 36)
|
|
|
Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment (up to Month 36)
Tidsramme: Baseline and final assessment (up to Month 36)
|
Baseline and final assessment (up to Month 36)
|
|
|
Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment (up to Month 36)
Tidsramme: Baseline and final assessment (up to Month 36)
|
Baseline and final assessment (up to Month 36)
|
|
|
Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment (up to Month 36)
Tidsramme: Baseline and final assessment (up to Month 36)
|
Baseline and final assessment (up to Month 36)
|
|
|
Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)
Tidsramme: Baseline and final assessment (up to Month 36)
|
Baseline and final assessment (up to Month 36)
|
|
|
Change From Baseline in Height at Final Assessment (up to Month 36)
Tidsramme: Baseline and final assessment (up to Month 36)
|
Baseline and final assessment (up to Month 36)
|
|
|
Number of Participants Who Had Lumbar Backache at Final Assessment (up to Month 36)
Tidsramme: Final assessment (up to Month 36)
|
Final assessment (up to Month 36)
|
|
|
Number of Participants Who Had One or More Adverse Drug Reactions
Tidsramme: Up to Month 36
|
Adverse drug reaction refers to adverse events related to the administered drug.
|
Up to Month 36
|
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)
13. mai 2013
Primær fullføring (Faktiske)
30. april 2018
Studiet fullført (Faktiske)
30. april 2018
Datoer for studieregistrering
Først innsendt
3. april 2014
Først innsendt som oppfylte QC-kriteriene
3. april 2014
Først lagt ut (Anslag)
8. april 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. juli 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. juli 2019
Sist bekreftet
1. juli 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Metabolske sykdommer
- Sår og skader
- Muskel- og skjelettsykdommer
- Beinsykdommer
- Bensykdommer, metabolske
- Brudd, bein
- Osteoporose
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Membrantransportmodulatorer
- Bone Density Conservation Agents
- Kalsiumregulerende hormoner og midler
- Kalsiumkanalblokkere
- Risedronsyre
Andre studie-ID-numre
- 178-002
- JapicCTI-142479 (Registeridentifikator: JapicCTI)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .