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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00143273
• Date of registration: 31/08/2005
• Prospective Registration: No
• Primary sponsor: Ligand Pharmaceuticals
• Public title: Dose Response Study of Lasofoxifene in Postmenopausal Women With Osteoporosis - Japanese Asian Dose Evaluation JADE
• Scientific title: Dose Response Study Of Lasofoxifene In Postmenopausal Women With Osteoporosis (Placebo-Controlled, Multicenter, Double-Blind, Comparative Study) - Japanese Asian Dose Evaluation: JADE
• Date of first enrolment: June 2004
• Target sample size: 497
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00143273
• 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
• Phase: Phase 2

Countries of recruitment

Japan, Korea, Republic of, Taiwan

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: 80 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Osteoporosis

Intervention(s)

Drug: Placebo

Drug: lasofoxifene

Primary Outcome(s)

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]

Secondary Outcome(s)

Hip BMD, bone markers, lipids and new radiographic vertebral fractures at 1 year [Time Frame: Month 6 and Month 12]

Secondary ID(s)

A2181037

Source(s) of Monetary Support

Please refer to primary and secondary sponsors