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Effects of Arzoxifene on Bone Mass and the Uterus

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00085956
First received: June 18, 2004
Last updated: March 7, 2007
Last verified: March 2007
History of Changes
  Purpose

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.

Condition Intervention Phase
Postmenopausal Bone Loss
 Drug: Arzoxifene
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Effects of Arzoxifene on Bone Mineral Density and Endometrial Histology in Postmenopausal Women.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 300
Study Start Date: April 2004
Estimated Study Completion Date: February 2007
  Eligibility

Ages Eligible for Study:   45 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00085956

Locations
United States, California
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, United States, 92103
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

Additional Information:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00085956     History of Changes
Other Study ID Numbers: 8537, H4Z-MC-GJAE
Study First Received: June 18, 2004
Last Updated: March 7, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis, Postmenopausal
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 23, 2013