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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
lasofoxifene
Placebo
Lasofoxifene
Lasofoxifene
Sponsored by
Ligand Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Lasofoxifene Dose 1

Lasofoxifene Dose 2

Lasofoxifene Dose 3

Placebo

Arm Description

0.05 mg

0.25 mg

0.5 mg

0 mg

Outcomes

Primary Outcome Measures

Effects of lasofoxifene compared to placebo on Bone Mineral Density (BMD) changes at the spine and hip after 1 year of treatment
Percent change from baseline in lumbar spine BMD at Month 12

Secondary Outcome Measures

Hip BMD, bone markers, lipids and new radiographic vertebral fractures at 1 year
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

Full Information

First Posted
August 31, 2005
Last Updated
August 8, 2011
Sponsor
Ligand Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00143273
Brief Title
Dose Response Study of Lasofoxifene in Postmenopausal Women With Osteoporosis - Japanese Asian Dose Evaluation
Acronym
JADE
Official Title
Dose Response Study Of Lasofoxifene In Postmenopausal Women With Osteoporosis (Placebo-Controlled, Multicenter, Double-Blind, Comparative Study) - Japanese Asian Dose Evaluation: JADE
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ligand Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
497 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lasofoxifene Dose 1
Arm Type
Experimental
Arm Description
0.05 mg
Arm Title
Lasofoxifene Dose 2
Arm Type
Experimental
Arm Description
0.25 mg
Arm Title
Lasofoxifene Dose 3
Arm Type
Experimental
Arm Description
0.5 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0 mg
Intervention Type
Drug
Intervention Name(s)
lasofoxifene
Intervention Description
0.05 mg tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0 mg
Intervention Type
Drug
Intervention Name(s)
Lasofoxifene
Intervention Description
0.25 mg tablets
Intervention Type
Drug
Intervention Name(s)
Lasofoxifene
Intervention Description
0.5 mg tablets
Primary Outcome Measure Information:
Title
Effects of lasofoxifene compared to placebo on Bone Mineral Density (BMD) changes at the spine and hip after 1 year of treatment
Description
Percent change from baseline in lumbar spine BMD at Month 12
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Hip BMD, bone markers, lipids and new radiographic vertebral fractures at 1 year
Description
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
Time Frame
Month 6 and Month 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
810-0021
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
892-0824
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
892-0845
Country
Japan
Facility Name
Pfizer Investigational Site
City
Miyazaki-shi
State/Province
Miyazaki
ZIP/Postal Code
880-0052
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fuchu
State/Province
Tokyo
ZIP/Postal Code
183-0051
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kiyose
State/Province
Tokyo
ZIP/Postal Code
204-0021
Country
Japan
Facility Name
Pfizer Investigational Site
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
106-0032
Country
Japan
Facility Name
Pfizer Investigational Site
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-0075
Country
Japan
Facility Name
Pfizer Investigational Site
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
157-0066
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yonago-shi
State/Province
Tottori
ZIP/Postal Code
683-8504
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kangnam-ku
State/Province
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Sonpagu
State/Province
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Youngdeungpo-gu
State/Province
Seoul
ZIP/Postal Code
150-713
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Changhua City 500
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taoyun 333
Country
Taiwan
Facility Name
Pfizer Investigational Site

12. IPD Sharing Statement

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

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