Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
207 participants
INTERVENTIONAL
2007-01-31
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Teriparatide
20 micrograms for 104 weeks
Teriparatide
daily, subcutaneous
Placebo
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
Teriparatide
daily, subcutaneous
Placebo
daily, subcutaneous
Interventions
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Teriparatide
daily, subcutaneous
Placebo
daily, subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged 55 or older
* Patients who are at high risk for fracture
Exclusion Criteria
* 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
55 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Eli Lilly
Principal Investigators
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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
Eli Lilly and Company
Locations
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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
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Fukuoka, , Japan
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Hokkaido, , Japan
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Hyōgo, , Japan
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Kagoshima, , Japan
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Kanagawa, , Japan
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Nagano, , Japan
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Nagasaki, , Japan
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Numakunai, , Japan
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Osaka, , Japan
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Ōita, , Japan
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Saitama, , Japan
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Shimane, , Japan
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Tokushima, , Japan
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Tokyo, , Japan
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Tottori, , Japan
Countries
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References
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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.
Other Identifiers
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B3D-JE-GHDB
Identifier Type: OTHER
Identifier Source: secondary_id
10494
Identifier Type: -
Identifier Source: org_study_id