NCT00085956

Brief Summary

The purposes of this study are to determine:

  • The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women.
  • The effects of arzoxifene on the uterus (womb) in postmenopausal women.
  • The effects of arzoxifene on blood tests that measure changes in bone rebuilding in postmenopausal women with low bone density.
  • The effects of arzoxifene on blood lipids (fats) and other blood markers of heart disease risk.
  • The safety of arzoxifene and any side effects that might be associated with its use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

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

April 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 22, 2004

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

March 9, 2007

Status Verified

March 1, 2007

First QC Date

June 18, 2004

Last Update Submit

March 7, 2007

Conditions

Postmenopausal Bone Loss

Outcome Measures

Primary Outcomes (3)

  • The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women

  • The effects of arzoxifene on the uterus (womb) in post menopausal women

  • The safety of arzoxifene and any side effects that might be associated with its use

Secondary Outcomes (3)

  • The effects of arzoxifene on blood tests that measure changes in bone rebuilding in postmenopausal women with low bone density

  • The effects of arzoxifene on blood lipids (fats) and other blood markers of heart disease

  • The effects of arzoxifene on breast density

Interventions

ArzoxifeneDRUG
PlaceboDRUG

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • to 60 years of age, inclusive
  • At least 2 years since last menstrual cycle
  • Intact uterus (womb).

You may not qualify if:

  • Existing fracture of the spine.
  • Bone disorders, other than low bone mass
  • History of cancer in the last 5 years. Also, any history, at any time, of breast cancer or cancer of the lining of the uterus.
  • Abnormal or unexplained vaginal bleeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

San Diego, California, 92103, United States

Location

Related Links

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

LY 353381

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 18, 2004

First Posted

June 22, 2004

Study Start

April 1, 2004

Study Completion

February 1, 2007

Last Updated

March 9, 2007

Record last verified: 2007-03

Locations

US(1)