Osteoporosis Clinical Trial
Official title:
Comparison of the Effects of Teriparatide With Those of Alendronate Sodium on Lumbar Spine Bone Mineral Density in Glucocorticoid-Induced Osteoporosis
| Verified date | February 2009 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 428 |
| Est. completion date | January 2008 |
| Est. primary completion date | July 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 21 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | 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 | Milwaukee | Wisconsin |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Austria, Belgium, Denmark, Norway, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD) | 18 month endpoint | No | |
| Secondary | Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset | 18 month endpoint | No | |
| Secondary | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | 3, 6, 12, 18, 24, 36 months | No | |
| Secondary | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset | 3, 6, 12, and 18 months | No | |
| Secondary | Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | 24 and 36 months and Endpoint at 36 months | No | |
| Secondary | Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | 18, 24, 36 months, and 18 and 36 month endpoints | No | |
| Secondary | Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | 18, 24, 36 months, and 18 and 36 month endpoints | No | |
| Secondary | Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | 12, 18, 24, and 36 months | No | |
| Secondary | Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | 12, 18, 24, and 36 months | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase | 1, 6, 18, and 36 months | No | |
| Secondary | 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 | No | |
| Secondary | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin | 1, 6, 18, and 36 months | No | |
| Secondary | Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures | 36 months | No |
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