Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis

Condition(s) targeted: Osteoporosis

Intervention: Teriparatide (Drug); Alendronate Sodium (Drug); Placebo (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company

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.

Official title: Comparison of the Effects of Teriparatide With Those of Alendronate Sodium on Lumbar Spine Bone Mineral Density in Glucocorticoid-Induced Osteoporosis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Secondary outcome:

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

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

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

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

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

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

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

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

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

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

Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase

Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments

Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin

Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

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, Graz, Austria

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, Vienna, Austria

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, Brussels, Belgium

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, Gent, Belgium

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, Leuven, Belgium

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, Aarhus, Denmark

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, Oslo, Norway

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, Carolina, Puerto Rico

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, Ponce, Puerto Rico

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

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, Palo Alto, California, United States

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, Aurora, Colorado, United States

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, Fargo, North Dakota, United States

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, Jamestown, North Dakota, United States

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, Milwaukee, Wisconsin, United States

Lilly Clinical Trial Registry

Starting date: November 2002
Last updated: February 13, 2009