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

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

        • Pfizer Investigational Site
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 810-0021
        • Pfizer Investigational Site
    • Kagoshima
      • Kagoshima-shi, Kagoshima, Japan, 892-0824
        • Pfizer Investigational Site
      • Kagoshima-shi, Kagoshima, Japan, 892-0845
        • Pfizer Investigational Site
    • Miyazaki
      • Miyazaki-shi, Miyazaki, Japan, 880-0052
        • Pfizer Investigational Site
    • Tokyo
      • Fuchu, Tokyo, Japan, 183-0051
        • Pfizer Investigational Site
      • Kiyose, Tokyo, Japan, 204-0021
        • Pfizer Investigational Site
      • Minato-ku, Tokyo, Japan, 106-0032
        • Pfizer Investigational Site
      • Minato-ku, Tokyo, Japan, 108-0075
        • Pfizer Investigational Site
      • Setagaya-ku, Tokyo, Japan, 157-0066
        • Pfizer Investigational Site
    • Tottori
      • Yonago-shi, Tottori, Japan, 683-8504
        • Pfizer Investigational Site
    • Seoul
      • Kangnam-ku, Seoul, Korea, Republic of, 135-710
        • Pfizer Investigational Site
      • Sonpagu, Seoul, Korea, Republic of, 138-736
        • Pfizer Investigational Site
      • Youngdeungpo-gu, Seoul, Korea, Republic of, 150-713
        • Pfizer Investigational Site
      • Changhua City 500, Taiwan
        • Pfizer Investigational Site
      • Taipei, Taiwan, 100
        • Pfizer Investigational Site
      • Taoyun 333, Taiwan
        • Pfizer Investigational Site

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
Experimental: Lasofoxifene Dose 1
0.05 mg
0.05 mg tablets
Experimental: Lasofoxifene Dose 2
0.25 mg
0.25 mg tablets
0.5 mg tablets
Experimental: Lasofoxifene Dose 3
0.5 mg
0.25 mg tablets
0.5 mg tablets

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
Percent change from baseline in lumbar spine BMD at Month 12
12 months

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
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
Month 6 and Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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