Phase 3
N=428
Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00051558 ↗Enrolled (actual)
428
Serious AEs
—
Results posted
Feb 2009
Primary outcome: Primary: Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD) — 0.059; 0.028 grams per square centimeters — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Teriparatide (Drug); Alendronate Sodium (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jul 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD) |
0.059; 0.028 | <0.001 sig |
| SECONDARY Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset |
0.056; 0.023 | <0.001 sig |
| SECONDARY Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined |
0.090; 0.044; 0.081; 0.043; 0.066; 0.031 | 0.058 |
| SECONDARY Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset |
0.062; 0.027; 0.052; 0.024; 0.031; 0.015 | 0.120 |
| SECONDARY Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined |
0.073; 0.034; 0.090; 0.044; 0.081; 0.043 | <0.001 sig |
| SECONDARY Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined |
0.033; 0.017; 0.041; 0.021; 0.030; 0.015 | <0.001 sig |
| SECONDARY Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined |
0.032; 0.017; 0.037; 0.020; 0.034; 0.018 | <0.001 sig |
| SECONDARY Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined |
0.041; 0.021; 0.030; 0.015; 0.028; 0.017 | <0.001 sig |
| SECONDARY Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined |
0.037; 0.020; 0.034; 0.018; 0.027; 0.018 | 0.011 sig |
| SECONDARY Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen |
107.0; -14.8; 130.8; -43.2; 86.3; -35.8 | <0.001 sig |
| SECONDARY Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen |
48.2; -8.8; 10.5; -22.3; 5.1; -21.3 | <0.001 sig |
| SECONDARY Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase |
35.0; 0.5; 52.3; -7.2; 34.4; -4.1 | <0.001 sig |
| SECONDARY Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments |
29.0; -38.6; 66.8; -42.4; 29.1; -47.5 | <0.001 sig |
| SECONDARY Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin |
147.1; -5.2; 120.0; -33.6; 108.9; -25.0 | <0.001 sig |
| SECONDARY Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures |
19; 27; 16; 15; 3; 13 | 0.212 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00051558). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.