Sequential Use of Teriparatide and Raloxifene HCl in the Treatment of Postmenopausal Women With Osteoporosis

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine whether the increase in spine bone mineral density that has been generally observed in previous clinical studies involving the study drug can be maintained or even increased if followed with raloxifene HCl. All qualifying study participants will receive the study drug followed by treatment with raloxifene HCl or placebo. All study participants will receive raloxifene HCl in the third phase of the study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Raloxifene Hydrochloride; Teriparatide

Criteria

Inclusion Criteria:

• Must be diagnosed with osteoporosis

• Must be female, age 55 through 80

• Must be at least 5 years postmenopausal

• Must be free of other severe or chronically disabling conditions

• Must be able to properly use injection device.

Exclusion Criteria:

• Must not have bone diseases other than osteoporosis

• Must not have history of certain cancers

• Must not have certain medical diseases (inflammatory bowel disease, malabsorption syndrome, kidney or bladder stones, venous thrombi or emboli, recent vaginal bleeding due to unknown causes)

• Must not have treatment with particular medications (warfarin, estrogens, androgens, steroids, calcitonins, fluorides, biphosphonates)

• Must not have known allergy to the study agent or raloxifene HCl