Study Comparing Arzoxifene With Raloxifene in Women After Menopause With Osteoporosis

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00383422
First received: September 29, 2006
Last updated: January 26, 2010
Last verified: January 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary BMD measures of total hip and femoral neck [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
  • Biochemical markers of bone metabolism assessed [ Time Frame: baseline, 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • Assessment of coagulation parameters [ Time Frame: baseline, 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • Breast Density by mammogram [ Time Frame: screening and 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years to 75 Years
Genders 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
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: 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:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00383422     History of Changes
Other Study ID Numbers: 8580, H4Z-MC-GJAR
Study First Received: September 29, 2006
Last Updated: January 26, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 21, 2014