Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis
NCT ID: NCT01992159
Last Updated: 2019-03-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
252 participants
INTERVENTIONAL
2012-10-12
2015-06-17
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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Placebo
Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
Placebo
Administered by subcutaneous injection
Romosozumab 70 mg
Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Romosozumab
Administered by subcutaneous injection
Romosozumab 140 mg
Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Romosozumab
Administered by subcutaneous injection
Romosozumab 210 mg
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Romosozumab
Administered by subcutaneous injection
Interventions
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Romosozumab
Administered by subcutaneous injection
Placebo
Administered by subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Use of agents affecting bone metabolism
* History of metabolic or bone disease (except osteoporosis)
* Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
* Current hyper- or hypocalcemia
* Current, uncontrolled hyper- or hypothyroidism
* Current, uncontrolled hyper- or hypoparathyroidism
55 Years
85 Years
FEMALE
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Anjyo-shi, Aichi-ken, Japan
Research Site
Fukuoka, Fukuoka, Japan
Research Site
Kitakyushu-shi, Fukuoka, Japan
Research Site
Yanagawa-shi, Fukuoka, Japan
Research Site
Mizunami-shi, Gifu, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Morioka, Iwate, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
Kyoto, Kyoto, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Saito-shi, Miyazaki, Japan
Research Site
Matsumoto-shi, Nagano, Japan
Research Site
Ueda-shi, Nagano, Japan
Research Site
Ueda-shi, Nagano, Japan
Research Site
Osaka, Osaka, Japan
Research Site
Takatsuki-shi, Osaka, Japan
Research Site
Kita-adachi-gun, Saitama, Japan
Research Site
Hachioji-shi, Tokyo, Japan
Research Site
Kiyose-shi, Tokyo, Japan
Research Site
Minato-ku, Tokyo, Japan
Research Site
Ōta-ku, Tokyo, Japan
Research Site
Shinagawa-ku, Tokyo, Japan
Research Site
Suginami-ku, Tokyo, Japan
Research Site
Toshima-ku, Tokyo, Japan
Countries
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References
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Ishibashi H, Crittenden DB, Miyauchi A, Libanati C, Maddox J, Fan M, Chen L, Grauer A. Romosozumab increases bone mineral density in postmenopausal Japanese women with osteoporosis: A phase 2 study. Bone. 2017 Oct;103:209-215. doi: 10.1016/j.bone.2017.07.005. Epub 2017 Jul 5.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20101291
Identifier Type: -
Identifier Source: org_study_id
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