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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Osteoporosis

ClinicalTrials.gov processed this record on October 23, 2014