Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis

Phase 3

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Alendronate Sodium; Drug: Teriparatide; Drug: Placebo

• Registration Number: NCT00051558
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2003-01-13
• Study First Submitted QC: 2003-01-13
• Study First Posted: 2003-01-14
• Primary Completion: 2006-07
• Study Completion: 2008-01
• Results First Submitted: 2009-01-14
• Results First Submitted QC: 2009-01-14
• Status Verified: 2009-02
• Results First Posted: 2009-02-13
• Last Update Submitted: 2009-02-13
• Last Update Posted: 2009-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 428

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Placebo	Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
B	Alendronate Sodium	Alendronate 10 mg/day oral plus injection placebo, 36 months
B	Placebo	Alendronate 10 mg/day oral plus injection placebo, 36 months
A	Teriparatide	Teriparatide 20 micrograms/day injection plus oral placebo, 36 months

Primary Outcome Measures

Name	Time	Method
Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)	18 month endpoint	change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)

Secondary Outcome Measures

Name	Time	Method
Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset	18 month endpoint	change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined	3, 6, 12, 18, 24, 36 months	change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset	3, 6, 12, and 18 months	change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined	24 and 36 months and Endpoint at 36 months	change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined	18, 24, 36 months, and 18 and 36 month endpoints	change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)
Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined	18, 24, 36 months, and 18 and 36 month endpoints	change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)
Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined	12, 18, 24, and 36 months	change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)
Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined	12, 18, 24, and 36 months	change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen	1, 6, 18, and 36 months
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen	1, 6, 18, and 36 months
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase	1, 6, 18, and 36 months
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments	1, 6, 18, and 36 months
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin	1, 6, 18, and 36 months
Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures	36 months	Clinical vertebral fracture was defined as a radiographically confirmed fracture that was associated with symptoms such as back pain.

Trial Locations

Locations (1)

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