Phase 3 Clinical Trial of Teriparatide in Japan
14 september 2010 bijgewerkt door: 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
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
207
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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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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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
55 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Teriparatide
20 micrograms for 104 weeks
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daily, subcutaneous
Andere namen:
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Placebo-vergelijker: 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
Andere namen:
daily, subcutaneous
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 januari 2007
Primaire voltooiing (Werkelijk)
1 september 2008
Studie voltooiing (Werkelijk)
1 september 2009
Studieregistratiedata
Eerst ingediend
7 februari 2007
Eerst ingediend dat voldeed aan de QC-criteria
7 februari 2007
Eerst geplaatst (Schatting)
9 februari 2007
Updates van studierecords
Laatste update geplaatst (Schatting)
21 september 2010
Laatste update ingediend die voldeed aan QC-criteria
14 september 2010
Laatst geverifieerd
1 september 2010
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 10494
- B3D-JE-GHDB (Andere identificatie: Eli Lilly and Company)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .