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Completed

NCT Number: NCT00143273

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

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

Completed

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

40 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Fukuoka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lasofoxifene

Drug

0.05 mg tablets

Placebo

Drug

0 mg

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ligand Pharmaceuticals

Industry

Registry information

Official study title

Dose Response Study Of Lasofoxifene In Postmenopausal Women With Osteoporosis (Placebo-Controlled, Multicenter, Double-Blind, Comparative Study) - Japanese Asian Dose Evaluation: JADE

Acronym: JADE

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 2, 2005
Registry last updated
Aug 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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