Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis

Eli Lilly and Company428 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

428

Conditions

Osteoporosis

Interventions

TeriparatideDRUG

20 micrograms/day, injection, 36 months

Alendronate SodiumDRUG

10 mg/day, oral, 36 months

PlaceboDRUG

Oral placebo, daily, 36 months

Placebo

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (15)

Outcomes

Primary Outcomes

Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)

change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)

Time frame: 18 month endpoint

Secondary Outcomes

Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset

change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)

Time frame: 18 month endpoint

Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined

change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)

Time frame: 3, 6, 12, 18, 24, 36 months

Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset

change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)

Time frame: 3, 6, 12, and 18 months

Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined

change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)

Time frame: 24 and 36 months and Endpoint at 36 months

Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined

change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)

Time frame: 18, 24, 36 months, and 18 and 36 month endpoints

Data from ClinicalTrials.gov

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Injection placebo, daily, 36 months

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Loma Linda, California, United States

Palo Alto, California, United States

Aurora, Colorado, United States

Fargo, North Dakota, United States

Jamestown, North Dakota, United States

Milwaukee, Wisconsin, United States

Graz, Austria

Vienna, Austria

Brussels, Belgium

Ghent, Belgium

...and 5 more locations

Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined

change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)

Time frame: 18, 24, 36 months, and 18 and 36 month endpoints

Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined

change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)

Time frame: 12, 18, 24, and 36 months

Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined

change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)

Time frame: 12, 18, 24, and 36 months

Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen