Study Comparing Arzoxifene With Raloxifene in Women After Menopause With Osteoporosis - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00383422

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Comparison of the Efficacy and Safety of Arzoxifene Versus Raloxifene in Postmenopausal Women With Osteoporosis

Resource links provided by NLM:

MedlinePlus related topics: Menopause Osteoporosis

Drug Information available for: Raloxifene hydrochloride Raloxifene Arzoxifene

U.S. FDA Resources

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
1: Experimental	Drug: Arzoxifene 20 mg, oral, tablet, once a day for 52 weeks
2: Active Comparator	Drug: Raloxifene 60 mg, oral, tablet, once a day for 52 weeks

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

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:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

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

Additional relevant MeSH terms:

Estrogen Antagonists
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Osteoporosis
Bone Diseases, Metabolic
Bone Density Conservation Agents

Selective Estrogen Receptor Modulators
Bone Diseases
Pharmacologic Actions
Estrogen Receptor Modulators
Raloxifene
Musculoskeletal Diseases
Osteoporosis, Postmenopausal

ClinicalTrials.gov processed this record on February 08, 2010