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

Ligand Pharmaceuticals497 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

497

Conditions

Osteoporosis

Interventions

lasofoxifeneDRUG

0.05 mg tablets

PlaceboDRUG

0 mg

LasofoxifeneDRUG

0.25 mg tablets

Lasofoxifene

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (17)

Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

Pfizer Investigational Site

Kagoshima, Kagoshima-ken, Japan

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

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

Time frame: Month 6 and Month 12

Data from ClinicalTrials.gov

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