Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00051558
First received: January 13, 2003
Last updated: February 13, 2009
Last verified: February 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoporosis |
Drug: Teriparatide Drug: Alendronate Sodium Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Comparison of the Effects of Teriparatide With Those of Alendronate Sodium on Lumbar Spine Bone Mineral Density in Glucocorticoid-Induced Osteoporosis |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD) [ Time Frame: 18 month endpoint ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset [ Time Frame: 18 month endpoint ] [ Designated as safety issue: No ]
- Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined [ Time Frame: 3, 6, 12, 18, 24, 36 months ] [ Designated as safety issue: No ]
- Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset [ Time Frame: 3, 6, 12, and 18 months ] [ Designated as safety issue: No ]
- Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined [ Time Frame: 24 and 36 months and Endpoint at 36 months ] [ Designated as safety issue: No ]
- Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined [ Time Frame: 18, 24, 36 months, and 18 and 36 month endpoints ] [ Designated as safety issue: No ]
- Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined [ Time Frame: 18, 24, 36 months, and 18 and 36 month endpoints ] [ Designated as safety issue: No ]
- Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined [ Time Frame: 12, 18, 24, and 36 months ] [ Designated as safety issue: No ]
- Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined [ Time Frame: 12, 18, 24, and 36 months ] [ Designated as safety issue: No ]
- Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-Terminal Propeptide of Type 1 Procollagen [ Time Frame: 1, 6, 18, and 36 months ] [ Designated as safety issue: No ]
- Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-Terminal Propeptide of Type 1 Procollagen [ Time Frame: 1, 6, 18, and 36 months ] [ Designated as safety issue: No ]
- Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase [ Time Frame: 1, 6, 18, and 36 months ] [ Designated as safety issue: No ]
- Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments [ Time Frame: 1, 6, 18, and 36 months ] [ Designated as safety issue: No ]
- Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin [ Time Frame: 1, 6, 18, and 36 months ] [ Designated as safety issue: No ]
- Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures [ Time Frame: 36 months ] [ Designated as safety issue: No ]
| Enrollment: | 428 |
| Study Start Date: | November 2002 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
|
Drug: Teriparatide
20 micrograms/day, injection, 36 months
Other Names:
Drug: Placebo
Oral placebo, daily, 36 months
|
|
Active Comparator: B
Alendronate 10 mg/day oral plus injection placebo, 36 months
|
Drug: Alendronate Sodium
10 mg/day, oral, 36 months
Drug: Placebo
Injection placebo, daily, 36 months
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00051558
Locations
| United States, California | |
| 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 | |
| United States, Colorado | |
| 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 | |
| United States, North Dakota | |
| 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 | |
| United States, Wisconsin | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| Aarhus, Denmark | |
| 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 | |
| Oslo, Norway | |
| 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 | |
| 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 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | 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) | Eli Lilly and Company |
More Information
Additional Information:
No publications provided by Eli Lilly and Company
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00051558 History of Changes |
| Other Study ID Numbers: | 6484, B3D-US-GHBZ |
| Study First Received: | January 13, 2003 |
| Results First Received: | January 14, 2009 |
| Last Updated: | February 13, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Glucocorticoids Alendronate |
Teriparatide Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on June 18, 2013