Clinical trial NCT00433160: Phase 3 Clinical Trial of Teriparatide in Japan
Official title: Efficacy and Safety of LY333334 in Japanese Patients With Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-02-09
Enrollment: 207
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)
timeFrame: Baseline to 52 weeks
Secondary outcomes:
measure: Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)
timeFrame: Baseline to 52 Weeks
measure: Percent Change in Bone Mineral Density (BMD) at Total Hip
timeFrame: Baseline to 52 Weeks
measure: Percent Change in Bone Mineral Density (BMD) at Femoral Neck
timeFrame: Baseline to 52 Weeks
measure: Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)
timeFrame: Baseline to Weeks 4, 12, 24, and 52
measure: Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)
timeFrame: Baseline to Weeks 4, 12, 24, 52
measure: Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX)
timeFrame: Baseline to Weeks 4, 12, 24, 52
measure: Vertebral Fractures by Central X-ray Assessment
timeFrame: Baseline through 52 weeks
measure: Fractures by Investigators Assessment
timeFrame: Baseline through 52 Weeks
measure: Back Pain Severity
timeFrame: Baseline, Weeks 12, 24, 36, 52
measure: Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks
timeFrame: Baseline, 76 Weeks, 104 Weeks
measure: Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks
timeFrame: Baseline, 76 Weeks, 104 Weeks
measure: Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks
timeFrame: Baseline, 76 Weeks, 104 Weeks
measure: Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks
timeFrame: Baseline, 76 Weeks, 104 Weeks
measure: 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
timeFrame: Baseline, 76 Weeks, 104 Weeks
measure: Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks
timeFrame: Baseline, 76 Weeks, 104 Weeks
measure: 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
timeFrame: Baseline, 76 Weeks, 104 Weeks
measure: Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks
timeFrame: Baseline through 104 Weeks
measure: Fractures by Investigators Assessment During Entire Study Period of 104 Weeks
timeFrame: Baseline Through 104 Weeks
measure: Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks
timeFrame: Baseline, 76 Weeks, 104 Weeks
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: 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.
city: Fukuoka
country: Japan
facility: 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.
city: Hokkaido
country: Japan
facility: 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.
city: Hyogo
country: Japan
facility: 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.
city: Iwate
country: Japan
facility: 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.
city: Kagoshima
country: Japan
facility: 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.
city: Kanagawa
country: Japan
facility: 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.
city: Nagano
country: Japan
facility: 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.
city: Nagasaki
country: Japan
facility: 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.
city: Oita
country: Japan
facility: 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.
city: Osaka
country: Japan
facility: 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.
city: Saitama
country: Japan
facility: 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.
city: Shimane
country: Japan
facility: 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.
city: Tokushima
country: Japan
facility: 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.
city: Tokyo
country: Japan
facility: 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.
city: Tottori
country: Japan
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.