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OpenTrials
Completed

NCT Number: NCT00085956

Effects of Arzoxifene on Bone Mass and the Uterus

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.

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Key information

Conditions

Postmenopausal Bone Loss Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

arzoxifene

Drug

Placebo

Drug

Primary outcomes

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

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

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

Secondary outcomes

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

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

  3. The effects of arzoxifene on breast density

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Effects of Arzoxifene on Bone Mineral Density and Endometrial Histology in Postmenopausal Women.

Important dates

Study start
2004
Study completion
2007
First posted
Jun 22, 2004
Registry last updated
Mar 9, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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