- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00143273
Dose Response Study of Lasofoxifene in Postmenopausal Women With Osteoporosis - Japanese Asian Dose Evaluation (JADE)
August 8, 2011 updated by: Ligand Pharmaceuticals
Dose Response Study Of Lasofoxifene In Postmenopausal Women With Osteoporosis (Placebo-Controlled, Multicenter, Double-Blind, Comparative Study) - Japanese Asian Dose Evaluation: JADE
To establish the optimal dose of lasofoxifene that is fully effective in increasing the BMD in postmenopausal Asian women.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
497
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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- Pfizer Investigational Site
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Fukuoka
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Fukuoka-shi, Fukuoka, Japan, 810-0021
- Pfizer Investigational Site
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Kagoshima
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Kagoshima-shi, Kagoshima, Japan, 892-0824
- Pfizer Investigational Site
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Kagoshima-shi, Kagoshima, Japan, 892-0845
- Pfizer Investigational Site
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Miyazaki
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Miyazaki-shi, Miyazaki, Japan, 880-0052
- Pfizer Investigational Site
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Tokyo
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Fuchu, Tokyo, Japan, 183-0051
- Pfizer Investigational Site
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Kiyose, Tokyo, Japan, 204-0021
- Pfizer Investigational Site
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Minato-ku, Tokyo, Japan, 106-0032
- Pfizer Investigational Site
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Minato-ku, Tokyo, Japan, 108-0075
- Pfizer Investigational Site
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Setagaya-ku, Tokyo, Japan, 157-0066
- Pfizer Investigational Site
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Tottori
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Yonago-shi, Tottori, Japan, 683-8504
- Pfizer Investigational Site
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Seoul
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Kangnam-ku, Seoul, Korea, Republic of, 135-710
- Pfizer Investigational Site
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Sonpagu, Seoul, Korea, Republic of, 138-736
- Pfizer Investigational Site
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Youngdeungpo-gu, Seoul, Korea, Republic of, 150-713
- Pfizer Investigational Site
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Changhua City 500, Taiwan
- Pfizer Investigational Site
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Taipei, Taiwan, 100
- Pfizer Investigational Site
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Taoyun 333, Taiwan
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
38 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- postmenopausal Asian women with osteoporosis defined by low BMD
Exclusion Criteria:
- Metabolic bone disease, use of other osteoporosis drugs or drugs interering with normal bone metabolism
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
0 mg
|
0 mg
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Experimental: Lasofoxifene Dose 1
0.05 mg
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0.05 mg tablets
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Experimental: Lasofoxifene Dose 2
0.25 mg
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0.25 mg tablets
0.5 mg tablets
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Experimental: Lasofoxifene Dose 3
0.5 mg
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0.25 mg tablets
0.5 mg tablets
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of lasofoxifene compared to placebo on Bone Mineral Density (BMD) changes at the spine and hip after 1 year of treatment
Time Frame: 12 months
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Percent change from baseline in lumbar spine BMD at Month 12
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hip BMD, bone markers, lipids and new radiographic vertebral fractures at 1 year
Time Frame: Month 6 and Month 12
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Percent change from baseline in lumbar spine BMD at Month 6, percent change in baseline in hip BMD at Month 6 and Month 12, percent change from baseline in bone metabolism markers at Month 6 and Month 12, percent change from baseline in serum lipids, total cholesterol, high-density lipoprotein cholesterol, triglycerides, lipoprotein (a), apoliporpotein-A1, apolipoprotein-B at Month 6 and Month 12 and incidence of new vertebral fractures at Month 12
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Month 6 and Month 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2004
Primary Completion (Actual)
March 1, 2006
Study Completion (Actual)
March 1, 2006
Study Registration Dates
First Submitted
August 31, 2005
First Submitted That Met QC Criteria
August 31, 2005
First Posted (Estimate)
September 2, 2005
Study Record Updates
Last Update Posted (Estimate)
August 10, 2011
Last Update Submitted That Met QC Criteria
August 8, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A2181037
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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