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Effects of Arzoxifene on Bone Mass and the Uterus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00085956
First Posted: June 22, 2004
Last Update Posted: March 9, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eli Lilly and Company
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00085956     History of Changes
Other Study ID Numbers: 8537
H4Z-MC-GJAE
First Submitted: June 18, 2004
First Posted: June 22, 2004
Last Update Posted: March 9, 2007
Last Verified: March 2007

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