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Study Comparing Arzoxifene With Raloxifene in Women After Menopause With Osteoporosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00383422
First Posted: October 3, 2006
Last Update Posted: January 28, 2010
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 purpose of this study is to compare the effect of arzoxifene to raloxifene on the bone mineral density (bone strength).

Condition Intervention Phase
Osteoporosis, Postmenopausal Drug: Arzoxifene Drug: Raloxifene Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Comparison of the Efficacy and Safety of Arzoxifene Versus Raloxifene in Postmenopausal Women With Osteoporosis

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Percent change in Lumbar Spine BMD [ Time Frame: baseline to 12 months ]

Secondary Outcome Measures:
  • Secondary BMD measures of total hip and femoral neck [ Time Frame: at 6 and 12 months ]
  • Biochemical markers of bone metabolism assessed [ Time Frame: baseline, 3, 6, and 12 months ]
  • Assessment of coagulation parameters [ Time Frame: baseline, 3, 6, and 12 months ]
  • Breast Density by mammogram [ Time Frame: screening and 12 months ]

Enrollment: 320
Study Start Date: October 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Arzoxifene
20 mg, oral, tablet, once a day for 52 weeks
Other Name: LY353381
Active Comparator: 2 Drug: Raloxifene
60 mg, oral, tablet, once a day for 52 weeks
Other Names:
  • LY139481
  • Evista

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have osteoporosis
  • Must be between 50 and 75 years old and be able to walk
  • Have at least two of your back bones that can be x-rayed
  • Have not had a period in at least two years
  • Be willing to have blood tests

Exclusion Criteria:

  • Have a bone disease other than osteoporosis
  • History of estrogen dependent cancer
  • History of stroke or certain heart problems
  • Possibly have an allergy to raloxifene or arzoxifene
  • Have certain abnormal lab values
  • History of seizure disorder
  • Have unexplained vaginal bleeding or an abnormal pap smear
  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): NCT00383422


  Show 21 Study Locations
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:
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00383422     History of Changes
Other Study ID Numbers: 8580
H4Z-MC-GJAR ( Other Identifier: Eli Lilly and Company )
First Submitted: September 29, 2006
First Posted: October 3, 2006
Last Update Posted: January 28, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Raloxifene Hydrochloride
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents