Phase 3 Clinical Trial of Teriparatide in Japan
14 settembre 2010 aggiornato da: 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
Panoramica dello studio
Tipo di studio
Interventistico
Iscrizione (Effettivo)
207
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
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Aichi, Giappone, 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.
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Fukuoka, Giappone, 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.
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Hokkaido, Giappone, 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.
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Hyogo, Giappone, 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.
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Iwate, Giappone, 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.
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Kagoshima, Giappone, 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.
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Kanagawa, Giappone, 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.
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Nagano, Giappone, 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.
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Nagasaki, Giappone, 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.
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Oita, Giappone, 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.
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Osaka, Giappone, 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.
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Saitama, Giappone, 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.
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Shimane, Giappone, 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.
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Tokushima, Giappone, 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.
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Tokyo, Giappone, 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.
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Tottori, Giappone, 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.
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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
55 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
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 |
|---|---|
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Sperimentale: Teriparatide
20 micrograms for 104 weeks
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daily, subcutaneous
Altri nomi:
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Comparatore placebo: Placebo
Placebo for 52 weeks.
After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
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daily, subcutaneous
Altri nomi:
daily, subcutaneous
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)
Lasso di tempo: Baseline to 52 weeks
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Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.
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Baseline to 52 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)
Lasso di tempo: Baseline to 52 Weeks
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Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.
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Baseline to 52 Weeks
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Percent Change in Bone Mineral Density (BMD) at Total Hip
Lasso di tempo: Baseline to 52 Weeks
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Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.
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Baseline to 52 Weeks
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Percent Change in Bone Mineral Density (BMD) at Femoral Neck
Lasso di tempo: Baseline to 52 Weeks
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Percent change in bone mineral density at femoral neck from baseline to the last measurement point.
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Baseline to 52 Weeks
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Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)
Lasso di tempo: Baseline to Weeks 4, 12, 24, and 52
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Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.
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Baseline to Weeks 4, 12, 24, and 52
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Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)
Lasso di tempo: Baseline to Weeks 4, 12, 24, 52
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Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.
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Baseline to Weeks 4, 12, 24, 52
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Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX)
Lasso di tempo: Baseline to Weeks 4, 12, 24, 52
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Percent change in serum type I collagen crosslinked C-telopeptide (CTX) from baseline to the individual visits and last measurement point.
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Baseline to Weeks 4, 12, 24, 52
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Vertebral Fractures by Central X-ray Assessment
Lasso di tempo: Baseline through 52 weeks
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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.
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Baseline through 52 weeks
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Fractures by Investigators Assessment
Lasso di tempo: Baseline through 52 Weeks
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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.
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Baseline through 52 Weeks
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Back Pain Severity
Lasso di tempo: Baseline, Weeks 12, 24, 36, 52
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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).
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Baseline, Weeks 12, 24, 36, 52
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Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks
Lasso di tempo: Baseline, 76 Weeks, 104 Weeks
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Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.
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Baseline, 76 Weeks, 104 Weeks
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Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks
Lasso di tempo: Baseline, 76 Weeks, 104 Weeks
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Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.
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Baseline, 76 Weeks, 104 Weeks
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Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks
Lasso di tempo: Baseline, 76 Weeks, 104 Weeks
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Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.
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Baseline, 76 Weeks, 104 Weeks
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Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks
Lasso di tempo: Baseline, 76 Weeks, 104 Weeks
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Percent change in bone mineral density at femoral neck from baseline to the last measurement point.
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Baseline, 76 Weeks, 104 Weeks
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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
Lasso di tempo: Baseline, 76 Weeks, 104 Weeks
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Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.
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Baseline, 76 Weeks, 104 Weeks
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Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks
Lasso di tempo: Baseline, 76 Weeks, 104 Weeks
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Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.
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Baseline, 76 Weeks, 104 Weeks
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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
Lasso di tempo: Baseline, 76 Weeks, 104 Weeks
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Percent change in serum type I collagen crosslinked C-telepeptide (CTX) from baseline to the individual visits and last measurement point.
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Baseline, 76 Weeks, 104 Weeks
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Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks
Lasso di tempo: Baseline through 104 Weeks
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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.
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Baseline through 104 Weeks
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Fractures by Investigators Assessment During Entire Study Period of 104 Weeks
Lasso di tempo: Baseline Through 104 Weeks
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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.
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Baseline Through 104 Weeks
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Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks
Lasso di tempo: Baseline, 76 Weeks, 104 Weeks
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Severity of back pain at 76 weeks and 104 weeks.
Back pain was measured on a scale of 1 (none) to 4 (severe).
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Baseline, 76 Weeks, 104 Weeks
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
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
- Miyauchi A, Matsumoto T, Sugimoto T, Tsujimoto M, Warner MR, Nakamura T. Effects of teriparatide on bone mineral density and bone turnover markers in Japanese subjects with osteoporosis at high risk of fracture in a 24-month clinical study: 12-month, randomized, placebo-controlled, double-blind and 12-month open-label phases. Bone. 2010 Sep;47(3):493-502. doi: 10.1016/j.bone.2010.05.022. Epub 2010 May 24.
- Yamamoto T, Tsujimoto M, Sowa H. Safety of daily teriparatide treatment: a post hoc analysis of a Phase III study to investigate the possible association of teriparatide treatment with calcium homeostasis in patients with serum procollagen type I N-terminal propeptide elevation. Clin Interv Aging. 2015 Jul 6;10:1101-9. doi: 10.2147/CIA.S83549. eCollection 2015.
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 gennaio 2007
Completamento primario (Effettivo)
1 settembre 2008
Completamento dello studio (Effettivo)
1 settembre 2009
Date di iscrizione allo studio
Primo inviato
7 febbraio 2007
Primo inviato che soddisfa i criteri di controllo qualità
7 febbraio 2007
Primo Inserito (Stima)
9 febbraio 2007
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
21 settembre 2010
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 settembre 2010
Ultimo verificato
1 settembre 2010
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 10494
- B3D-JE-GHDB (Altro identificatore: Eli Lilly and Company)
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 .