Phase 3 Clinical Trial of Teriparatide in Japan
14. september 2010 oppdatert av: 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
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
207
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
55 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Teriparatide
20 micrograms for 104 weeks
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daily, subcutaneous
Andre navn:
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Placebo komparator: 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
Andre navn:
daily, subcutaneous
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
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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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2007
Primær fullføring (Faktiske)
1. september 2008
Studiet fullført (Faktiske)
1. september 2009
Datoer for studieregistrering
Først innsendt
7. februar 2007
Først innsendt som oppfylte QC-kriteriene
7. februar 2007
Først lagt ut (Anslag)
9. februar 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
21. september 2010
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. september 2010
Sist bekreftet
1. september 2010
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 10494
- B3D-JE-GHDB (Annen identifikator: Eli Lilly and Company)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .