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Effects of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis

29 avril 2008 mis à jour par: Eli Lilly and Company

Effects of LY333334 in the Treatment of Postmenopausal Women With Osteoporosis

The primary objective of this study is to demonstrate a reduction in the proportion of new vertebral fractures in postmenopausal women with osteoporosis following 3-years of treatment with 20 and 40 mcg/day of teriparatide plus calcium and vitamin D compared with calcium and vitamin D alone.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

1637

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

  • Argentine
      • Capital Federal, Argentine
        • 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.
  • Australie
      • Nedlands, Australie
        • 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.
  • Belgique
      • Brussels, Belgique
        • 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.
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • 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.
  • Danemark
      • Aarhus, Danemark
        • 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.
  • Finlande
      • Kuopio, Finlande
        • 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.
  • Hongrie
      • Szeged, Hongrie
        • 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.
  • Israël
      • Tel-Hashomer, Israël
        • 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.
  • Italie
      • Arenzano, Italie
        • 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.
  • L'Autriche
      • Graz, L'Autriche
        • 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.
  • Norvège
      • Kristiansand, Norvège
        • 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.
  • Nouvelle-Zélande
      • Christchurch, Nouvelle-Zélande
        • 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.
  • Pays-Bas
      • Amsterdam, Pays-Bas
        • 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.
  • Pologne
      • Warszawa, Pologne
        • 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.
  • République tchèque
      • Praha, République tchèque
        • 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.
  • Suède
      • Uppsala, Suède
        • 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.
  • États-Unis
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02114
        • 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

30 ans à 85 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  • Ambulatory, postmenopausal women.
  • A minimum of either one moderate or two mild atraumatic vertebral fractures, and a minimum of seven evaluable nonfractured vertebrae.
  • Hip BMD or lumbar spine BMD measurement at least 1.0 standard deviation (SD) below the average bone mass for young, healthy women (T-score) only in patients with fewer than two moderate fractures or in patients previously treated with therapeutic doses of bisphosphonates or fluorides
  • Normal or clinically nonsignificant abnormal laboratory values (serum calcium, PTH(1-84), & urine calcium must be within normal limits at baseline; 25-hydroxyvitamin D must be between the lower limit of normal & 3 times the upper limit of normal at baseline).

Exclusion Criteria:

  • Fractures in areas of bone affected by diseases other than osteoporosis (for example, cancer or Paget's disease).
  • Satisfactory baseline thoracic and lumbar spinal x-ray views cannot be obtained as determined by the centralized x-ray quality assurance center (for example, severe scoliosis or kyphosis).
  • Current or recent (within 1 year prior to randomization) metabolic bone disorders other than postmenopausal osteoporosis, such as Paget's disease, renal osteodystrophy, osteomalacia, or any secondary causes of osteoporosis
  • Current or recent (within 1 year prior to randomization) disease which affects bone metabolism, such as hypoparathyroidism, hyperparathyroidism, or hyperthyroidism.
  • Currently suspected carcinoma or history of carcinoma in the 5 years prior to randomization.
  • Nephrolithiasis or urolithiasis in the 2 years prior to randomization.
  • Current or recent (within 1 year prior to randomization) sprue, inflammatory bowel disease, or malabsorption syndrome, or any indication of poor intestinal absorption of calcium, such as the combination of a low urinary calcium excretion and an elevated serum intact parathyroid hormone level.
  • Poor medical or psychiatric risk for treatment with an investigational drug, in the opinion of the investigator.
  • Treatment with androgens or other anabolic steroids in the 6 months prior to randomization.
  • Treatment with calcitonins in the 2 months prior to randomization.
  • Treatment with estrogen
  • Treatment with progestins in the 3 calendar months prior to randomization, or for more than 2 months in the 12 calendar months prior to randomization.
  • Treatment with corticosteroids.
  • Treatment with fluorides in the 6 months prior to randomization or for more than 60 days in the 24 months prior to randomization.
  • Treatment with oral bisphosphonates in the 3 months prior to randomization or for more than 60 days in the 24 months prior to randomization; treatment with intravenous bisphosphonates in the 24 months prior to randomization.
  • Treatment with vitamin D >50,000 IU/week, or with any dose of calcitriol, analogs, or agonists in the 6 months prior to randomization. The 25-hydroxyvitamin D laboratory value at randomization must be between the lower limit of normal and three times the upper limit of normal.
  • Treatment with coumarins and indandione derivatives in the 3 months prior to randomization; treatment with heparins >10,000 U/day for more than 30 days in the 6 months prior to randomization.
  • Treatment with calcium- or aluminum-containing antacids
  • Treatment with any other drug known to affect bone metabolism in the 6 months prior to randomization.
  • Treatment with any investigational drug during the month prior to the calcium and vitamin D run-in phase. Treatment with investigational drugs in certain therapeutic classes during the month prior to the calcium & vitamin D run-in phase.

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: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 1
LY333334 40 micrograms/day plus calcium and vitamin D
Médicament: teriparatide
40 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
Autres noms:
  • Fortéo
  • LY333334
  • Forsteo
Médicament: teriparatide
20 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
Autres noms:
  • Fortéo
  • LY333334
  • Forsteo
Médicament: Calcium Supplement
Approximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement
Médicament: Vitamin D Supplement
Approximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement
Expérimental: 2
LY333334 20 micrograms/day plus calcium and vitamin D
Médicament: teriparatide
40 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
Autres noms:
  • Fortéo
  • LY333334
  • Forsteo
Médicament: teriparatide
20 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
Autres noms:
  • Fortéo
  • LY333334
  • Forsteo
Médicament: Calcium Supplement
Approximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement
Médicament: Vitamin D Supplement
Approximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement
Comparateur placebo: 3
Placebo plus calcium and vitamin D
Médicament: Calcium Supplement
Approximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement
Médicament: Vitamin D Supplement
Approximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement
Médicament: Placebo
Placebo for subcutaneous injection will be supplied in a prefilled injection device with a cartridge identical in appearance to the LY333334 device.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
To demonstrate a reduction in the proportion of patients with new vertebral fractures (by spinal x-ray) following 3-year treatment with 20 and 40 micrograms/day of LY333334 plus calcium and vitamin D compared with calcium and vitamin D alone.
Délai: Baseline, randomization, 24 , 36, and 60 months
Baseline, randomization, 24 , 36, and 60 months

Mesures de résultats secondaires

Mesure des résultats
Délai
To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on lumbar spine and hip BMD in postmenopausal women with osteoporosis
Délai: Lumbar Spine: Randomization -2wks, Randomization,( 3 & 6 months in a subset of pts), 12 , 18 , 24 , 36 , 48 & 60 months. Hip BMD: Randomization -2wks, Randomization, 12 , 24 , 36 , 48 & 60 months.
Lumbar Spine: Randomization -2wks, Randomization,( 3 & 6 months in a subset of pts), 12 , 18 , 24 , 36 , 48 & 60 months. Hip BMD: Randomization -2wks, Randomization, 12 , 24 , 36 , 48 & 60 months.
To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on total body and radial (forearm) BMD in postmenopausal women with osteoporosis at selected study sites
Délai: Randomization, 12, 24, 36, 48 and 60 months
Randomization, 12, 24, 36, 48 and 60 months
To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on the rate of new vertebral fractures (by spinal x-ray) in postmenopausal women with osteoporosis.
Délai: Baseline, randomization, 24 months, 60 months
Baseline, randomization, 24 months, 60 months
To establish the effect of treatment with LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone, by x-ray on the proportion of subjects experiencing new nonvertebral fractures alone & new nonvertebral & vertebral fractures combined.
Délai: As clinically needed throughout the trial
As clinically needed throughout the trial
To assess the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on height (via Harpenden stadiometer or other suitable stadiometer) in postmenopausal women with osteoporosis
Délai: Randomization, 12, 24, 36, 48, and 60 months
Randomization, 12, 24, 36, 48, and 60 months
To determine the histomorphometric effects of LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone by biopsy, on the iliac crest (bone formation & resorption, mineralization, and trabecular structure) in a subset of subjects.
Délai: Randomization, 12 and 24 months
Randomization, 12 and 24 months
To assess effects of LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone, on biochemical markers of bone formation & resorption (bone-specific alkaline phosphatase, PICP, urinary N-telopeptide, & urinary free deoxypyridinolines)
Délai: Randomization, 1, 3, 6, 12, 24, 36, 48, and 60 months
Randomization, 1, 3, 6, 12, 24, 36, 48, and 60 months
To assess population pharmacokinetics of LY333334 at selected study sites. Nonlinear mixed effect modeling [NONMEM])and or PTH(1-84) will be employed to evaluate serum concentrations of LY333334.
Délai: Months 1, 3, 6, 12, 18, 24, 30, 36 and 60
Months 1, 3, 6, 12, 18, 24, 30, 36 and 60
To quantify medical resources used by patients during the study so that a cost-effectiveness analysis can be performed.
Délai: Randomization, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 Months
Randomization, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 Months
To assess the impact of LY333334 on health-related quality of life in postmenopausal women with osteoporosis. Quality of life instruments will be completed where translated and validated instruments are available.
Délai: Randomization, 12, 24, 36, 48, and 60 months
Randomization, 12, 24, 36, 48, and 60 months
To establish the safety of chronic administration of LY333334 in postmenopausal women with osteoporosis. Adverse events, physical examinations and laboratory tests will be used to assess safety in the patients.
Délai: Adverse Events: throughout the trial. Labs:Baseline, randomization, 1, 6, 12, 24, 36, 48, and 60 months. Physical Exams: 12, 24, 36, 48, and 60 months
Adverse Events: throughout the trial. Labs:Baseline, randomization, 1, 6, 12, 24, 36, 48, and 60 months. Physical Exams: 12, 24, 36, 48, and 60 months

Collaborateurs et enquêteurs

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

Parrainer

Eli Lilly and Company

Les enquêteurs

  • Directeur d'études: Call 1-877-CT LILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), 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 août 1996

Achèvement primaire (Réel)

1 avril 1999

Achèvement de l'étude (Réel)

1 avril 1999

Dates d'inscription aux études

Première soumission

29 avril 2008

Première soumission répondant aux critères de contrôle qualité

29 avril 2008

Première publication (Estimation)

1 mai 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

1 mai 2008

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 avril 2008

Dernière vérification

1 avril 2008

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 547
  • B3D-MC-GHAC

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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