Effects of Arzoxifene on Bone Fractures and Incidence of Breast Cancer

Lilly

Status and phase: Completed; Phase 3

Conditions: Osteoporosis, Postmenopausal

Treatments: Drug: Arzoxifene; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00088010

H4Z-MC-GJAD (Other Identifier)

8536

Details and patient eligibility

About

The purpose of this trial is to study:

• Effects of arzoxifene on bone fractures and bone mass.
• Effects of arzoxifene on getting breast cancer.
• Effects of arzoxifene on certain types of cardiovascular events, such as heart attack and stroke.
• Effects of arzoxifene that changes the amount of certain substances in the blood that are related to osteoporosis and cardiovascular health.
• Effects of arzoxifene on the uterus.
• The safety of arzoxifene and any side effects.

Enrollment: 9,369 patients

Sex: Female

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 60-85 years of age
• Female
• At least two years since last menstrual cycle

Exclusion criteria

• Abnormal or unexplained vaginal bleeding.
• Bone disorders, other than osteoporosis or low bone mass
• History of breast cancer, cancer of the uterus, or any cancer in the last five years (except skin cancer).
• History of cerebral vascular accidents or venous thromboembolic events
• Medications outlined

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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9,369 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Arzoxifene

2

Placebo Comparator group

Treatment:

Drug: Placebo