Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis

Study Overview
=================
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.

Official Title
-----------------
Comparison of the Effects of Teriparatide With Those of Alendronate Sodium on Lumbar Spine Bone Mineral Density in Glucocorticoid-Induced Osteoporosis

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Teriparatide
* Drug: Alendronate Sodium
* Drug: Placebo
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Teriparatide 20 micrograms/day injection plus oral placebo, 36 months | Drug: Teriparatide<br>* 20 micrograms/day, injection, 36 months<br>* Other names: Forsteo;Drug: Placebo<br>* Oral placebo, daily, 36 months<br>|
| Active Comparator: B<br>Alendronate 10 mg/day oral plus injection placebo, 36 months | Drug: Alendronate Sodium<br>* 10 mg/day, oral, 36 months<br>Drug: Placebo<br>* Injection placebo, daily, 36 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset | change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA) | 18 month endpoint | 
| Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA) | 3, 6, 12, 18, 24, 36 months | 
| Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset | change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA) | 3, 6, 12, and 18 months | 
| Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA) | 24 and 36 months and Endpoint at 36 months | 
| Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA) | 18, 24, 36 months, and 18 and 36 month endpoints | 
| Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA) | 18, 24, 36 months, and 18 and 36 month endpoints | 
| Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA) | 12, 18, 24, and 36 months | 
| Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA) | 12, 18, 24, and 36 months | 
| 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 | Clinical vertebral fracture was defined as a radiographically confirmed fracture that was associated with symptoms such as back pain. | 36 months |