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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
History of Changes
  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:

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

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
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 May 16, 2013