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Dose Response Study of Lasofoxifene in Postmenopausal Women With Osteoporosis - Japanese Asian Dose Evaluation

NCT ID: NCT00143273

Last Updated: 2011-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

497 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-03-31

Brief Summary

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To establish the optimal dose of lasofoxifene that is fully effective in increasing the BMD in postmenopausal Asian women.

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Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lasofoxifene Dose 1

0.05 mg

Group Type EXPERIMENTAL

lasofoxifene

Intervention Type DRUG

0.05 mg tablets

Lasofoxifene Dose 2

0.25 mg

Group Type EXPERIMENTAL

Lasofoxifene

Intervention Type DRUG

0.25 mg tablets

Lasofoxifene Dose 3

0.5 mg

Group Type EXPERIMENTAL

Lasofoxifene

Intervention Type DRUG

0.5 mg tablets

Placebo

0 mg

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0 mg

Interventions

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lasofoxifene

0.05 mg tablets

Intervention Type DRUG

Placebo

0 mg

Intervention Type DRUG

Lasofoxifene

0.25 mg tablets

Intervention Type DRUG

Lasofoxifene

0.5 mg tablets

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ligand Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Ligand Pharmaceuticals

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Kagoshima, Kagoshima-ken, Japan

Site Status

Pfizer Investigational Site

Kagoshima, Kagoshima-ken, Japan

Site Status

Pfizer Investigational Site

Miyazaki, Miyazaki, Japan

Site Status

Pfizer Investigational Site

Fuchū, Tokyo, Japan

Site Status

Pfizer Investigational Site

Kiyose, Tokyo, Japan

Site Status

Pfizer Investigational Site

Minato-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Minato-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Setagaya-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Yonago-shi, Tottori, Japan

Site Status

Pfizer Investigational Site

Kangnam-ku, Seoul, South Korea

Site Status

Pfizer Investigational Site

Sonpagu, Seoul, South Korea

Site Status

Pfizer Investigational Site

Youngdeungpo-gu, Seoul, South Korea

Site Status

Pfizer Investigational Site

Changhua, , Taiwan

Site Status

Pfizer Investigational Site

Taipei, , Taiwan

Site Status

Pfizer Investigational Site

Taoyun 333, , Taiwan

Site Status

Pfizer Investigational Site

, ,

Site Status

Countries

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Japan South Korea Taiwan

Other Identifiers

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A2181037

Identifier Type: -

Identifier Source: org_study_id

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