Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis

Lilly

Status and phase: Completed; Phase 3

Conditions: Osteoporosis

Treatments: Drug: Alendronate Sodium; Drug: Placebo; Drug: Teriparatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00051558

B3D-US-GHBZ

6484

Details and patient eligibility

About

Osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and there is an increased risk for fractures. Glucocorticoids (such as prednisone) are prescribed to treat a large number of conditions such as arthritis and asthma. When taken for several months or longer, glucocorticoids can cause bone loss and lead to a form of osteoporosis called "glucocorticoid-induced osteoporosis." This study compared the effects of teriparatide, the study drug, with alendronate, an approved drug for treating glucocorticoid-induced osteoporosis.

Enrollment: 428 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or women age 21 years or older
• Taking on average 5.0 mg/day prednisone or equivalent for at least 3 months prior to screening

Exclusion criteria

• Taking bisphosphonates within past 6 months
• More than 30 micrograms/day of estradiol or equivalent in past 3 months
• History of alcoholism or drug abuse in past year
• Pregnant women or nursing mothers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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428 participants in 2 patient groups

A

Experimental group

Description:

Teriparatide 20 micrograms/day injection plus oral placebo, 36 months

Treatment:

Drug: Teriparatide

Drug: Placebo

Drug: Placebo

B

Active Comparator group

Description:

Alendronate 10 mg/day oral plus injection placebo, 36 months

Treatment:

Drug: Alendronate Sodium

Drug: Placebo

Drug: Placebo