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Phase 3 Clinical Trial of Teriparatide in Japan

14 septembre 2010 mis à jour par: 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

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

207

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Japon
      • Aichi, Japon, 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, Japon, 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, Japon, 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, Japon, 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, Japon, 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, Japon, 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, Japon, 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, Japon, 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, Japon, 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, Japon, 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, Japon, 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, Japon, 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, Japon, 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, Japon, 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, Japon, 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, Japon, 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.

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

55 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Teriparatide
20 micrograms for 104 weeks
Médicament: Teriparatide
daily, subcutaneous
Autres noms:
  • Fortéo
  • LY333334
  • Forsteo
Comparateur placebo: Placebo
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
Médicament: Teriparatide
daily, subcutaneous
Autres noms:
  • Fortéo
  • LY333334
  • Forsteo
Médicament: Placebo
daily, subcutaneous

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Eli Lilly and Company

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2007

Achèvement primaire (Réel)

1 septembre 2008

Achèvement de l'étude (Réel)

1 septembre 2009

Dates d'inscription aux études

Première soumission

7 février 2007

Première soumission répondant aux critères de contrôle qualité

7 février 2007

Première publication (Estimation)

9 février 2007

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

21 septembre 2010

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 septembre 2010

Dernière vérification

1 septembre 2010

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 10494
  • B3D-JE-GHDB (Autre identifiant: Eli Lilly and Company)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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