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

10. februar 2016 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

308

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

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

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Ibandronate
Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.
Andre navn:
  • Bonviva/Boniva
Eksperimentell: 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.
Legemiddel: Ibandronate
Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.
Andre navn:
  • Bonviva/Boniva

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hoffmann-La Roche

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

1. august 2004

Primær fullføring (Faktiske)

1. mai 2006

Studiet fullført (Faktiske)

1. mai 2006

Datoer for studieregistrering

Først innsendt

4. november 2015

Først innsendt som oppfylte QC-kriteriene

4. november 2015

Først lagt ut (Anslag)

6. november 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

9. mars 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. februar 2016

Sist bekreftet

1. februar 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ML18057

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. .

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