Phase 3 Clinical Trial of Teriparatide in Japan

Osteoporosis Clinical Trial

Official title:

Efficacy and Safety of LY333334 in Japanese Patients With Osteoporosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00433160
• Other study ID #: 10494
• Secondary ID: B3D-JE-GHDB
• Status: Completed
• Phase: Phase 3
• First received: February 7, 2007
• Last updated: September 14, 2010
• Start date: January 2007
• Est. completion date: September 2009

Study information

• Verified date: September 2010
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy of teriparatide based on measurements of bone mineral density at lumbar spine

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: September 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Teriparatide
daily, subcutaneous
• Placebo
daily, subcutaneous

Locations

Country	Name	City	State
Japan	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.	Aichi
Japan	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.	Fukuoka
Japan	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.	Hokkaido
Japan	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.	Hyogo
Japan	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.	Iwate
Japan	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.	Kagoshima
Japan	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.	Kanagawa
Japan	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.	Nagano
Japan	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.	Nagasaki
Japan	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.	Oita
Japan	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.	Osaka
Japan	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.	Saitama
Japan	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.	Shimane
Japan	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.	Tokushima
Japan	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.	Tokyo
Japan	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.	Tottori

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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, rand — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)	Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.	Baseline to 52 weeks	No
Secondary	Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)	Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.	Baseline to 52 Weeks	No
Secondary	Percent Change in Bone Mineral Density (BMD) at Total Hip	Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.	Baseline to 52 Weeks	No
Secondary	Percent Change in Bone Mineral Density (BMD) at Femoral Neck	Percent change in bone mineral density at femoral neck from baseline to the last measurement point.	Baseline to 52 Weeks	No
Secondary	Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)	Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.	Baseline to Weeks 4, 12, 24, and 52	No
Secondary	Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)	Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.	Baseline to Weeks 4, 12, 24, 52	No
Secondary	Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX)	Percent change in serum type I collagen crosslinked C-telopeptide (CTX) from baseline to the individual visits and last measurement point.	Baseline to Weeks 4, 12, 24, 52	No
Secondary	Vertebral Fractures by Central X-ray Assessment	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.	Baseline through 52 weeks	No
Secondary	Fractures by Investigators Assessment	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.	Baseline through 52 Weeks	No
Secondary	Back Pain Severity	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).	Baseline, Weeks 12, 24, 36, 52	No
Secondary	Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks	Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.	Baseline, 76 Weeks, 104 Weeks	No
Secondary	Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks	Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.	Baseline, 76 Weeks, 104 Weeks	No
Secondary	Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks	Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.	Baseline, 76 Weeks, 104 Weeks	No
Secondary	Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks	Percent change in bone mineral density at femoral neck from baseline to the last measurement point.	Baseline, 76 Weeks, 104 Weeks	No
Secondary	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	Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.	Baseline, 76 Weeks, 104 Weeks	No
Secondary	Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks	Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.	Baseline, 76 Weeks, 104 Weeks	No
Secondary	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	Percent change in serum type I collagen crosslinked C-telepeptide (CTX) from baseline to the individual visits and last measurement point.	Baseline, 76 Weeks, 104 Weeks	No
Secondary	Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks	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.	Baseline through 104 Weeks	No
Secondary	Fractures by Investigators Assessment During Entire Study Period of 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.	Baseline Through 104 Weeks	No
Secondary	Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks	Severity of back pain at 76 weeks and 104 weeks. Back pain was measured on a scale of 1 (none) to 4 (severe).	Baseline, 76 Weeks, 104 Weeks	No

External Links

•   Lilly Clinical Trial Registry