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Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis

13 febbraio 2009 aggiornato da: Eli Lilly and Company

Comparison of the Effects of Teriparatide With Those of Alendronate Sodium on Lumbar Spine Bone Mineral Density in Glucocorticoid-Induced Osteoporosis

Osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and there is an increased risk for fractures. Glucocorticoids (such as prednisone) are prescribed to treat a large number of conditions such as arthritis and asthma. When taken for several months or longer, glucocorticoids can cause bone loss and lead to a form of osteoporosis called "glucocorticoid-induced osteoporosis." This study compared the effects of teriparatide, the study drug, with alendronate, an approved drug for treating glucocorticoid-induced osteoporosis.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

428

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Austria
      • Graz, Austria
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Vienna, Austria
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • Belgio
      • Brussels, Belgio
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Gent, Belgio
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Leuven, Belgio
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • Danimarca
      • Aarhus, Danimarca
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • Norvegia
      • Oslo, Norvegia
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • Porto Rico
      • Carolina, Porto Rico
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Ponce, Porto Rico
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • Stati Uniti
    • California
      • Loma Linda, California, Stati Uniti
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Palo Alto, California, Stati Uniti
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
    • Colorado
      • Aurora, Colorado, Stati Uniti
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
    • North Dakota
      • Fargo, North Dakota, Stati Uniti
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Jamestown, North Dakota, Stati Uniti
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
    • Wisconsin
      • Milwaukee, Wisconsin, Stati Uniti
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

21 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Men or women age 21 years or older
  • Taking on average 5.0 mg/day prednisone or equivalent for at least 3 months prior to screening

Exclusion Criteria:

  • Taking bisphosphonates within past 6 months
  • More than 30 micrograms/day of estradiol or equivalent in past 3 months
  • History of alcoholism or drug abuse in past year
  • Pregnant women or nursing mothers

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: A
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
Droga: Teriparatide
20 micrograms/day, injection, 36 months
Altri nomi:
  • Forteo
  • LY333334
  • Forsteo
Droga: Placebo
Oral placebo, daily, 36 months
Droga: Placebo
Injection placebo, daily, 36 months
Comparatore attivo: B
Alendronate 10 mg/day oral plus injection placebo, 36 months
Droga: Placebo
Oral placebo, daily, 36 months
Droga: Placebo
Injection placebo, daily, 36 months
Droga: Alendronate Sodium
10 mg/day, oral, 36 months

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)
Lasso di tempo: 18 month endpoint
change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
18 month endpoint

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset
Lasso di tempo: 18 month endpoint
change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
18 month endpoint
Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
Lasso di tempo: 3, 6, 12, 18, 24, 36 months
change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
3, 6, 12, 18, 24, 36 months
Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset
Lasso di tempo: 3, 6, 12, and 18 months
change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
3, 6, 12, and 18 months
Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
Lasso di tempo: 24 and 36 months and Endpoint at 36 months
change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
24 and 36 months and Endpoint at 36 months
Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
Lasso di tempo: 18, 24, 36 months, and 18 and 36 month endpoints
change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)
18, 24, 36 months, and 18 and 36 month endpoints
Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
Lasso di tempo: 18, 24, 36 months, and 18 and 36 month endpoints
change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)
18, 24, 36 months, and 18 and 36 month endpoints
Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
Lasso di tempo: 12, 18, 24, and 36 months
change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)
12, 18, 24, and 36 months
Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
Lasso di tempo: 12, 18, 24, and 36 months
change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)
12, 18, 24, and 36 months
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen
Lasso di tempo: 1, 6, 18, and 36 months
1, 6, 18, and 36 months
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen
Lasso di tempo: 1, 6, 18, and 36 months
1, 6, 18, and 36 months
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase
Lasso di tempo: 1, 6, 18, and 36 months
1, 6, 18, and 36 months
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments
Lasso di tempo: 1, 6, 18, and 36 months
1, 6, 18, and 36 months
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin
Lasso di tempo: 1, 6, 18, and 36 months
1, 6, 18, and 36 months
Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures
Lasso di tempo: 36 months
Clinical vertebral fracture was defined as a radiographically confirmed fracture that was associated with symptoms such as back pain.
36 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Eli Lilly and Company

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2002

Completamento primario (Effettivo)

1 luglio 2006

Completamento dello studio (Effettivo)

1 gennaio 2008

Date di iscrizione allo studio

Primo inviato

13 gennaio 2003

Primo inviato che soddisfa i criteri di controllo qualità

13 gennaio 2003

Primo Inserito (Stima)

14 gennaio 2003

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

12 marzo 2009

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 febbraio 2009

Ultimo verificato

1 febbraio 2009

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 6484
  • B3D-US-GHBZ

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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