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

Osteoporosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00143273
• Other study ID #: A2181037
• Status: Completed
• Phase: Phase 2
• First received: August 31, 2005
• Last updated: August 8, 2011
• Start date: June 2004
• Est. completion date: March 2006

Study information

• Verified date: August 2011
• Source: Ligand Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 497
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• lasofoxifene
0.05 mg tablets
• Placebo
0 mg
• Lasofoxifene
0.25 mg tablets
• Lasofoxifene
0.5 mg tablets

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Fuchu	Tokyo
Japan	Pfizer Investigational Site	Fukuoka-shi	Fukuoka
Japan	Pfizer Investigational Site	Kagoshima-shi	Kagoshima
Japan	Pfizer Investigational Site	Kagoshima-shi	Kagoshima
Japan	Pfizer Investigational Site	Kiyose	Tokyo
Japan	Pfizer Investigational Site	Minato-ku	Tokyo
Japan	Pfizer Investigational Site	Minato-ku	Tokyo
Japan	Pfizer Investigational Site	Miyazaki-shi	Miyazaki
Japan	Pfizer Investigational Site	Setagaya-ku	Tokyo
Japan	Pfizer Investigational Site	Unknown	Tokyo
Japan	Pfizer Investigational Site	Yonago-shi	Tottori
Korea, Republic of	Pfizer Investigational Site	Kangnam-ku	Seoul
Korea, Republic of	Pfizer Investigational Site	Sonpagu	Seoul
Korea, Republic of	Pfizer Investigational Site	Youngdeungpo-gu	Seoul
Taiwan	Pfizer Investigational Site	Changhua City 500
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taoyun 333

Sponsors (1)

Lead Sponsor	Collaborator
Ligand Pharmaceuticals

Countries where clinical trial is conducted

Japan,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Secondary	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	Month 6 and Month 12