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Effects of Arzoxifene on Bone Fractures and Incidence of Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00088010
First received: July 19, 2004
Last updated: May 27, 2010
Last verified: May 2010
History of Changes
  Purpose

The purpose of this trial is to study:

  • Effects of arzoxifene on bone fractures and bone mass.
  • Effects of arzoxifene on getting breast cancer.
  • Effects of arzoxifene on certain types of cardiovascular events, such as heart attack and stroke.
  • Effects of arzoxifene that changes the amount of certain substances in the blood that are related to osteoporosis and cardiovascular health.
  • Effects of arzoxifene on the uterus.
  • The safety of arzoxifene and any side effects.

Condition Intervention Phase
Osteoporosis, Postmenopausal
 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 (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Arzoxifene on Vertebral Fracture Incidence and on Invasive Breast Cancer Incidence in Postmenopausal Women With Osteoporosis or With Low Bone Density.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Effects of arzoxifene on bone fractures and bone mass [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Effects of arzoxifene on getting breast cancer [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • The safety of arzoxifene and any side effects [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effects of arzoxifene on certain types of cardiovascular events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Effects of arzoxifene that changes the amount of certain substances in the blood that are related to osteoporosis and cardiovascular health [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Effects of arzoxifene on the uterus [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Effects of arzoxifene on cognition [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Effects of arzoxifene on back pain [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 9369
Study Start Date: June 2004
Study Completion Date: November 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Arzoxifene
20mg, oral, tablet, once a day for 36 months
Other Name: LY353381
Placebo Comparator: 2 Drug: Placebo
oral, tablet, once a day for 36 months

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 60-85 years of age
  • Female
  • At least two years since last menstrual cycle

Exclusion Criteria:

  • Abnormal or unexplained vaginal bleeding.
  • Bone disorders, other than osteoporosis or low bone mass
  • History of breast cancer, cancer of the uterus, or any cancer in the last five years (except skin cancer).
  • History of cerebral vascular accidents or venous thromboembolic events
  • Medications outlined
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00088010

Locations
United States, Illinois
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 - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Elk Grove, Illinois, United States, 60007
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 by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00088010     History of Changes
Other Study ID Numbers: 8536, H4Z-MC-GJAD
Study First Received: July 19, 2004
Last Updated: May 27, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Osteoporosis
Osteoporosis, Postmenopausal
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on June 18, 2013