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36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Sodium Risedronate 75 mg Tablets

18. juli 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

579

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

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Osteoporosis

Beskrivelse

Inclusion Criteria:

Osteoporosis patients who meet all the following criteria:

  1. 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)
  2. Male and postmenopausal female patients aged 50 years or older
  3. Ambulatory outpatients

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
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.
Medicin: Sodium risedronate
Sodium risedronate tablets

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

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)

13. maj 2013

Primær færdiggørelse (Faktiske)

30. april 2018

Studieafslutning (Faktiske)

30. april 2018

Datoer for studieregistrering

Først indsendt

3. april 2014

Først indsendt, der opfyldte QC-kriterier

3. april 2014

Først opslået (Skøn)

8. april 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juli 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juli 2019

Sidst verificeret

1. juli 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 178-002
  • JapicCTI-142479 (Registry Identifier: JapicCTI)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Sodium risedronate

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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Betingelser

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