NCT00143273

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
497

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2004

Geographic Reach
3 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

August 10, 2011

Status Verified

August 1, 2011

Enrollment Period

1.7 years

First QC Date

August 31, 2005

Last Update Submit

August 8, 2011

Conditions

Osteoporosis

Outcome Measures

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

    Percent change from baseline in lumbar spine BMD at Month 12

    12 months

Secondary Outcomes (1)

  • Hip BMD, bone markers, lipids and new radiographic vertebral fractures at 1 year

    Month 6 and Month 12

Study Arms (4)

Lasofoxifene Dose 1

EXPERIMENTAL

0.05 mg

Drug: lasofoxifene

Lasofoxifene Dose 2

EXPERIMENTAL

0.25 mg

Drug: Lasofoxifene

Lasofoxifene Dose 3

EXPERIMENTAL

0.5 mg

Drug: Lasofoxifene

Placebo

PLACEBO COMPARATOR

0 mg

Drug: Placebo

Interventions

LasofoxifeneDRUG

0.05 mg tablets

Lasofoxifene Dose 1
PlaceboDRUG

0 mg

Placebo

Eligibility Criteria

Age40 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • postmenopausal Asian women with osteoporosis defined by low BMD

You may not qualify if:

  • Metabolic bone disease, use of other osteoporosis drugs or drugs interering with normal bone metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Pfizer Investigational Site

Fukuoka, Fukuoka, 810-0021, Japan

Location

Pfizer Investigational Site

Kagoshima, Kagoshima-ken, 892-0824, Japan

Location

Pfizer Investigational Site

Kagoshima, Kagoshima-ken, 892-0845, Japan

Location

Pfizer Investigational Site

Miyazaki, Miyazaki, 880-0052, Japan

Location

Pfizer Investigational Site

Fuchū, Tokyo, 183-0051, Japan

Location

Pfizer Investigational Site

Kiyose, Tokyo, 204-0021, Japan

Location

Pfizer Investigational Site

Minato-ku, Tokyo, 106-0032, Japan

Location

Pfizer Investigational Site

Minato-ku, Tokyo, 108-0075, Japan

Location

Pfizer Investigational Site

Setagaya-ku, Tokyo, 157-0066, Japan

Location

Pfizer Investigational Site

Yonago-shi, Tottori, 683-8504, Japan

Location

Pfizer Investigational Site

Kangnam-ku, Seoul, 135-710, South Korea

Location

Pfizer Investigational Site

Sonpagu, Seoul, 138-736, South Korea

Location

Pfizer Investigational Site

Youngdeungpo-gu, Seoul, 150-713, South Korea

Location

Pfizer Investigational Site

Changhua, Taiwan

Location

Pfizer Investigational Site

Taipei, 100, Taiwan

Location

Pfizer Investigational Site

Taoyun 333, Taiwan

Location

Pfizer Investigational Site

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Lasofoxifene

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 2, 2005

Study Start

June 1, 2004

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

August 10, 2011

Record last verified: 2011-08

Locations

KR(3)JP(10)TW(3)