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Completed

NCT Number: NCT00383422

Study Comparing Arzoxifene With Raloxifene in Women After Menopause With Osteoporosis

The purpose of this study is to compare the effect of arzoxifene to raloxifene on the bone mineral density (bone strength).

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Key information

Conditions

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

Age range

50 year–75 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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

arzoxifene

Drug

20 mg, oral, tablet, once a day for 52 weeks

Other names: LY353381

Raloxifene

Drug

60 mg, oral, tablet, once a day for 52 weeks

Other names: LY139481, Evista

Primary outcomes

  1. Percent change in Lumbar Spine BMD

    Time frame: baseline to 12 months

Secondary outcomes

  1. Secondary BMD measures of total hip and femoral neck

    Time frame: at 6 and 12 months

  2. Biochemical markers of bone metabolism assessed

    Time frame: baseline, 3, 6, and 12 months

  3. Assessment of coagulation parameters

    Time frame: baseline, 3, 6, and 12 months

  4. Breast Density by mammogram

    Time frame: screening and 12 months

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

The Comparison of the Efficacy and Safety of Arzoxifene Versus Raloxifene in Postmenopausal Women With Osteoporosis

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Oct 3, 2006
Registry last updated
Jan 28, 2010

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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