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A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis

10. februar 2016 opdateret af: Hoffmann-La Roche

A Prospective Open-Label, Multicenter Study to Evaluate the Change in Bone Turnover Markers After Once Monthly Oral Ibandronate Therapy in Treatment Naive Postmenopausal Osteoporosis Patients

This study will evaluate whether an early positive response to once-monthly oral ibandronate in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy later in treatment. The anticipated time on study treatment is 6 months, and the target sample size is 360 individuals.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

308

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Montgomery, Alabama, Forenede Stater, 36111
    • Arizona
      • Chandler, Arizona, Forenede Stater, 85225
      • Peoria, Arizona, Forenede Stater, 85381
    • Arkansas
      • Hot Springs, Arkansas, Forenede Stater, 71913
      • Pine Bluff, Arkansas, Forenede Stater, 71603
    • California
      • Anaheim, California, Forenede Stater, 92801
      • Beverly Hills, California, Forenede Stater, 90211
      • Carmichael, California, Forenede Stater, 95608
    • Delaware
      • Wilmington, Delaware, Forenede Stater, 19805
    • Florida
      • Deland, Florida, Forenede Stater, 32720
      • Miami, Florida, Forenede Stater, 33186
      • Miami, Florida, Forenede Stater, 33176
      • Palm Habor, Florida, Forenede Stater, 34684
      • Palm Springs, Florida, Forenede Stater, 33461
      • West Palm Beach, Florida, Forenede Stater, 33409
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30309
      • Rome, Georgia, Forenede Stater, 30165
    • Illinois
      • Morton Grove, Illinois, Forenede Stater, 60053
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
    • Iowa
      • Waterloo, Iowa, Forenede Stater, 50702
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21209
      • Hagerstown, Maryland, Forenede Stater, 21740
      • Reistertown, Maryland, Forenede Stater, 21136
    • Mississippi
      • Olive Branch, Mississippi, Forenede Stater, 38654
    • Missouri
      • Jefferson City, Missouri, Forenede Stater, 65109
      • St Louis, Missouri, Forenede Stater, 63108
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68131
    • New Jersey
      • Bloomfield, New Jersey, Forenede Stater, 07003
    • New York
      • Bronx, New York, Forenede Stater, 10461
      • New York, New York, Forenede Stater, 10016
    • North Carolina
      • Morehead City, North Carolina, Forenede Stater, 28557
      • Morganton, North Carolina, Forenede Stater, 28655
      • Raleigh, North Carolina, Forenede Stater, 27612
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73112
    • Oregon
      • Medford, Oregon, Forenede Stater, 97504
    • Pennsylvania
      • Doylestown, Pennsylvania, Forenede Stater, 18901
      • Langhorne, Pennsylvania, Forenede Stater, 19047
      • Philadelphia, Pennsylvania, Forenede Stater, 19131
    • South Carolina
      • Mount Pleasant, South Carolina, Forenede Stater, 29464
      • Spartanburg, South Carolina, Forenede Stater, 29307
    • Tennessee
      • Morristown, Tennessee, Forenede Stater, 37813
      • Murfreesboro, Tennessee, Forenede Stater, 37130
      • Nashville, Tennessee, Forenede Stater, 37203
    • Texas
      • Amarillo, Texas, Forenede Stater, 79106
      • Fort Worth, Texas, Forenede Stater, 76101
      • San Antonio, Texas, Forenede Stater, 78229
      • Texarkana, Texas, Forenede Stater, 75503
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23226
    • Washington
      • Tacoma, Washington, Forenede Stater, 98405
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53705
  • Puerto Rico
      • Ponce, Puerto Rico, 00717-1318
      • San Juan, Puerto Rico, 00935
      • San Juan, Puerto Rico, 00927

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

Kvinde

Beskrivelse

Inclusion Criteria:

  • Women newly diagnosed with postmenopausal osteoporosis
  • Naive to prior bisphosphonate therapy

Exclusion Criteria:

  • Inability to stand or sit upright for at least 60 minutes
  • Inability to swallow a tablet whole
  • Hypersensitivity to any component of ibandronate
  • Hormone (estrogen) replacement therapy within last 3 months, or will start on therapy within next 6 months
  • Other osteoporosis drug within last 3 months
  • Malignant disease diagnosed within previous 10 years, except resected basal cell cancer

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Ibandronate Group 1
Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 1 will receive a physician consultation after 4 months of treatment to review bone turnover test results.
Medicin: Ibandronate
Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.
Andre navne:
  • Bonviva/Boniva
Eksperimentel: Ibandronate Group 2
Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 2 will not receive a physician consultation.
Medicin: Ibandronate
Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.
Andre navne:
  • Bonviva/Boniva

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX)
Tidsramme: Baseline, Month 6
Serum CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
Baseline, Month 6

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent Change From Baseline to Month 6 in Urine N-terminal Telopeptide of Type 1 Collagen (NTX)
Tidsramme: Baseline, Month 6
Urine NTX is a measure of bone resorption and is measured as millimoles bone collagen equivalents per millimoles creatinine. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
Baseline, Month 6
Percent Change From Baseline to Month 6 in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)
Tidsramme: Baseline, Month 6
Serum P1NP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus Baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
Baseline, Month 6
Percent Change From Baseline to Month 6 in Serum Osteocalcin
Tidsramme: Baseline, Month 6
Serum osteocalcin is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
Baseline, Month 6
Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (BSAP)
Tidsramme: Baseline, Month 6
Serum BSAP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
Baseline, Month 6
Percentage of Participants Who Were "Very Confident" or "Confident" to Items on the Boniva Confidence Scale (BCS) at Month 6
Tidsramme: Month 6
The BCS is designed to measure the participant's confidence level that Boniva (ibandronate) therapy is effective in treating osteoporosis and reducing the risk of fracture. Response options ranged on a 5-point scale from 'Not At All Confident' to 'Very Confident.' A Boniva confidence responder was defined as a participant who reported a response of 'confident' or 'very confident' on the 2 items in BCS. (1) ibandronate was effective in treating osteoporosis and (2) ibandronate reduces the risk of breaking a bone.
Month 6

Samarbejdspartnere og efterforskere

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

Sponsor

Hoffmann-La Roche

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

1. august 2004

Primær færdiggørelse (Faktiske)

1. maj 2006

Studieafslutning (Faktiske)

1. maj 2006

Datoer for studieregistrering

Først indsendt

4. november 2015

Først indsendt, der opfyldte QC-kriterier

4. november 2015

Først opslået (Skøn)

6. november 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. februar 2016

Sidst verificeret

1. februar 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ML18057

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 Osteoporose efter overgangsalderen

Kliniske forsøg med Ibandronate

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Ireland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner