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

This study has been completed.
Sponsor:
Information provided by:
Ligand Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00143273
First received: August 31, 2005
Last updated: August 8, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Osteoporosis
Drug: lasofoxifene
Drug: Placebo
Drug: Lasofoxifene
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dose Response Study Of Lasofoxifene In Postmenopausal Women With Osteoporosis (Placebo-Controlled, Multicenter, Double-Blind, Comparative Study) - Japanese Asian Dose Evaluation: JADE

Resource links provided by NLM:


Further study details as provided by Ligand Pharmaceuticals:

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 [ Time Frame: 12 months ]
    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 [ 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


Enrollment: 497
Study Start Date: June 2004
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lasofoxifene Dose 1
0.05 mg
Drug: lasofoxifene
0.05 mg tablets
Experimental: Lasofoxifene Dose 2
0.25 mg
Drug: Lasofoxifene
0.25 mg tablets
Experimental: Lasofoxifene Dose 3
0.5 mg
Drug: Lasofoxifene
0.5 mg tablets
Placebo Comparator: Placebo
0 mg
Drug: Placebo
0 mg

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143273

Locations
Japan
Pfizer Investigational Site
Fukuoka-shi, Fukuoka, Japan, 810-0021
Pfizer Investigational Site
Kagoshima-shi, Kagoshima, Japan, 892-0824
Pfizer Investigational Site
Kagoshima-shi, Kagoshima, Japan, 892-0845
Pfizer Investigational Site
Miyazaki-shi, Miyazaki, Japan, 880-0052
Pfizer Investigational Site
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
Unknown, Tokyo, Japan, 192-0065
Pfizer Investigational Site
Yonago-shi, Tottori, Japan, 683-8504
Korea, Republic of
Pfizer Investigational Site
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
Taiwan
Pfizer Investigational Site
Changhua City 500, Taiwan
Pfizer Investigational Site
Taipei, Taiwan, 100
Pfizer Investigational Site
Taoyun 333, Taiwan
Sponsors and Collaborators
Ligand Pharmaceuticals
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

Responsible Party: Director, Project Management, Ligand Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00143273     History of Changes
Other Study ID Numbers: A2181037
Study First Received: August 31, 2005
Last Updated: August 8, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 24, 2014