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Phase 3 Clinical Trial of Teriparatide in Japan

14. September 2010 aktualisiert von: Eli Lilly and Company

Efficacy and Safety of LY333334 in Japanese Patients With Osteoporosis

To evaluate the efficacy of teriparatide based on measurements of bone mineral density at lumbar spine

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

207

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Japan
      • Aichi, Japan, 454-0933
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Fukuoka, Japan, 811-2101
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Hokkaido, Japan, 070-0034
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Hyogo, Japan, 655-0853
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Iwate, Japan, 020-8505
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kagoshima, Japan, 890-0014
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kanagawa, Japan, 231-0023
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nagano, Japan, 386-0493
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nagasaki, Japan, 854-0083
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Oita, Japan, 879-7125
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Osaka, Japan, 555-0032
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Saitama, Japan, 358-0007
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Shimane, Japan, 693-0021
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tokushima, Japan, 770-8503
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tokyo, Japan, 163-0202
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tottori, Japan, 683-0853
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

55 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Japanese patients diagnosed with osteoporosis
  • Aged 55 or older
  • Patients who are at high risk for fracture

Exclusion Criteria:

  • History of metabolic bone disorders other than primary osteoporosis
  • History of malignant neoplasm in the 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated.
  • Severe or chronically disabling conditions other than osteoporosis

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Teriparatide
20 micrograms for 104 weeks
Arzneimittel: Teriparatide
daily, subcutaneous
Andere Namen:
  • Forteo
  • LY333334
  • Forsteo
Placebo-Komparator: Placebo
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
Arzneimittel: Teriparatide
daily, subcutaneous
Andere Namen:
  • Forteo
  • LY333334
  • Forsteo
Arzneimittel: Placebo
daily, subcutaneous

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)
Zeitfenster: Baseline to 52 weeks
Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.
Baseline to 52 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)
Zeitfenster: Baseline to 52 Weeks
Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.
Baseline to 52 Weeks
Percent Change in Bone Mineral Density (BMD) at Total Hip
Zeitfenster: Baseline to 52 Weeks
Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.
Baseline to 52 Weeks
Percent Change in Bone Mineral Density (BMD) at Femoral Neck
Zeitfenster: Baseline to 52 Weeks
Percent change in bone mineral density at femoral neck from baseline to the last measurement point.
Baseline to 52 Weeks
Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)
Zeitfenster: Baseline to Weeks 4, 12, 24, and 52
Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.
Baseline to Weeks 4, 12, 24, and 52
Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)
Zeitfenster: Baseline to Weeks 4, 12, 24, 52
Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.
Baseline to Weeks 4, 12, 24, 52
Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX)
Zeitfenster: Baseline to Weeks 4, 12, 24, 52
Percent change in serum type I collagen crosslinked C-telopeptide (CTX) from baseline to the individual visits and last measurement point.
Baseline to Weeks 4, 12, 24, 52
Vertebral Fractures by Central X-ray Assessment
Zeitfenster: Baseline through 52 weeks
Number of vertebral fractures observed from Visit 1 (study entry) through Visit 19 (Week 52). All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted.
Baseline through 52 weeks
Fractures by Investigators Assessment
Zeitfenster: Baseline through 52 Weeks
Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be "fragility" if they occurred without trauma.
Baseline through 52 Weeks
Back Pain Severity
Zeitfenster: Baseline, Weeks 12, 24, 36, 52
Severity of back pain at baseline, individual visits and the last measurement point. Back pain was measured on a scale of 1 (none) to 4 (severe).
Baseline, Weeks 12, 24, 36, 52
Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks
Zeitfenster: Baseline, 76 Weeks, 104 Weeks
Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.
Baseline, 76 Weeks, 104 Weeks
Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks
Zeitfenster: Baseline, 76 Weeks, 104 Weeks
Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.
Baseline, 76 Weeks, 104 Weeks
Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks
Zeitfenster: Baseline, 76 Weeks, 104 Weeks
Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.
Baseline, 76 Weeks, 104 Weeks
Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks
Zeitfenster: Baseline, 76 Weeks, 104 Weeks
Percent change in bone mineral density at femoral neck from baseline to the last measurement point.
Baseline, 76 Weeks, 104 Weeks
Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks
Zeitfenster: Baseline, 76 Weeks, 104 Weeks
Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.
Baseline, 76 Weeks, 104 Weeks
Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks
Zeitfenster: Baseline, 76 Weeks, 104 Weeks
Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.
Baseline, 76 Weeks, 104 Weeks
Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks
Zeitfenster: Baseline, 76 Weeks, 104 Weeks
Percent change in serum type I collagen crosslinked C-telepeptide (CTX) from baseline to the individual visits and last measurement point.
Baseline, 76 Weeks, 104 Weeks
Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks
Zeitfenster: Baseline through 104 Weeks
Number of vertebral fractures observed from Visit 1 (study entry) through 104 weeks. All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted.
Baseline through 104 Weeks
Fractures by Investigators Assessment During Entire Study Period of 104 Weeks
Zeitfenster: Baseline Through 104 Weeks
Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be "fragility" if they occurred without trauma.
Baseline Through 104 Weeks
Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks
Zeitfenster: Baseline, 76 Weeks, 104 Weeks
Severity of back pain at 76 weeks and 104 weeks. Back pain was measured on a scale of 1 (none) to 4 (severe).
Baseline, 76 Weeks, 104 Weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Eli Lilly and Company

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Januar 2007

Primärer Abschluss (Tatsächlich)

1. September 2008

Studienabschluss (Tatsächlich)

1. September 2009

Studienanmeldedaten

Zuerst eingereicht

7. Februar 2007

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Februar 2007

Zuerst gepostet (Schätzen)

9. Februar 2007

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

21. September 2010

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. September 2010

Zuletzt verifiziert

1. September 2010

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 10494
  • B3D-JE-GHDB (Andere Kennung: Eli Lilly and Company)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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