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
  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:


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
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: 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:
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 July 28, 2014