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

Lilly

Status and phase

Completed

Phase 4

Conditions

Osteoporosis, Postmenopausal

Treatments

Drug: placebo

Drug: raloxifene HCl

Drug: teriparatide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00035256

B3D-MC-GHBQ

5490

Details and patient eligibility

About

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.

Sex

Female

Ages

55 to 80 years old

Volunteers

No Healthy Volunteers

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