Study Comparing Arzoxifene With Raloxifene in Women After Menopause With Osteoporosis

Lilly

Status and phase: Completed; Phase 3

Conditions: Osteoporosis, Postmenopausal

Treatments: Drug: Raloxifene; Drug: Arzoxifene

Study type: Interventional

Funder types: Industry

Identifiers

NCT00383422

8580

H4Z-MC-GJAR (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 320 patients

Sex: Female

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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320 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Arzoxifene

2

Active Comparator group

Treatment:

Drug: Raloxifene