| January 13, 2003 |
| February 13, 2009 |
| November 2002 |
| July 2006 (final data collection date for primary outcome measure) |
| Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD) [ Time Frame: 18 month endpoint ] [ Designated as safety issue: No ] |
- - Whether the increase from baseline to 18 months in lumbar spine BMD induced by teriparatide statistically signficantly exceeds that obtained with alendronate in women and men taking GC for a minimum of 3 months
- To determine:
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| Complete list of historical versions of study NCT00051558 on ClinicalTrials.gov Archive Site |
- 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 ]
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- - Whether the increase from baseline to 18 months in lumbar spine BMD induced by teriparatide statistically significantly exceeds that obtained with alendronate in women taking GC for a minimum of 3 months
- - The time course of BMD response at the lumbar spine from baseline until 18 months in women and men combined, and in women separately
- To assess the effects of the therapies on:
- - The change from baseline in femoral neck and total hip BMD at 18 months, 24 months, and 36 months, and in lumbar spine BMD at 24 months and 36 months
- - The time course of BMD response at the femoral neck and total hip from baseline until 18 months
- - The time course of BMD response at the lumbar spine, femoral neck, and total hip from baseline until 36 months
- - The time course of response of biochemical markers of bone turnover from baseline until 18 months in subjects from a subset of the study centers
- - The time course of response of biochemical markers of bone turnover from baseline until 36 months in subjects from a subset of the study centers
- - Any fracture, nonvertebral fractures, vertebral fractures, clinical vertebral fractures, and severity fractures at 36 months
- - Adverse experience, laboratory variables, and other aspects of subject safety and tolerance of the study drugs
|
| |
| Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis |
| Comparison of the Effects of Teriparatide With Those of Alendronate Sodium on Lumbar Spine Bone Mineral Density in Glucocorticoid-Induced Osteoporosis |
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. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Osteoporosis |
- Drug: Teriparatide
- Drug: Alendronate Sodium
- Drug: Placebo
|
- Experimental: Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
- Active Comparator: Alendronate 10 mg/day oral plus injection placebo, 36 months
|
| Saag KG, Shane E, Boonen S, Marín F, Donley DW, Taylor KA, Dalsky GP, Marcus R. Teriparatide or alendronate in glucocorticoid-induced osteoporosis. N Engl J Med. 2007 Nov 15;357(20):2028-39. |
| |
| Completed |
| 428 |
| January 2008 |
| July 2006 (final data collection date for primary outcome measure) |
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
|
| Both |
| 21 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Austria, Belgium, Denmark, Norway, Puerto Rico |
| |
| NCT00051558 |
| Chief Medical Officer, Eli Lilly |
| 6484, B3D-US-GHBZ |
| Eli Lilly and Company |
|
| 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 |
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|
| Eli Lilly and Company |
| February 2009 |