The Forteo Alendronate Comparator Trial

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate the effects of teriparatide with those of alendronate on spine bone mineral density (BMD) and other osteoporosis factors in postmenopausal women with osteoporosis.

Official Title
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Teriparatide Compared With Alendronate on Spine Bone Mineral Density in Postmenopausal Women With Osteoporosis

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Teriparatide
* Drug: Alendronate
* Dietary Supplement: Calcium
* Dietary Supplement: Vitamin D
* Drug: Placebo-Oral
* Drug: Placebo-SC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal women with osteoporosis. Ambulatory, 5 years or more past menopause. BMD T score between -2.5 and -4.0 at the lumbar spine or femoral neck. Normal or clinically insignificant abnormal laboratory values, including serum calcium, parathyroid hormone (PTH) 1-84, 25-hydroxyvitamin D, and alkaline phosphatase. Exclusion Criteria: Prior treatment with PTH or a PTH analogue. Treatment with bisphosphonates within 12 months, anabolic corticosteroids or calcitriol or vitamin D analogues or agonists within 6 months, estrogens or selective estrogen receptor modulators within 3 months, or calcitonin within 2 months; therapeutic doses of fluoride; systemic corticosteroid use within 1 month or for more than 30 days in the prior year; use of anticoagulants within 1 month. History of diseases other than postmenopausal osteoporosis that affect bone metabolism. History of an increased risk of osteosarcoma (ie, patients with Paget disease of bone, previous skeletal exposure to external beam radiotherapy, or previous malignant neoplasm involving the skeleton). Malignant neoplasms within 5 years; carcinoma in situ of the uterine cervix within 1 year. Nephrolithiasis or urolithiasis within 2 years, or impaired renal function. Abnormal uncorrected thyroid function. Liver disease or clinical jaundice. Alcohol or other drug abuse. Poor medical or psychiatric risk for treatment.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teriparatide<br>20 micrograms per day teriparatide subcutaneous (SC) injection plus oral placebo for 18 months. | Drug: Teriparatide<br>* Administered SC<br>* Other names: Forsteo;Dietary Supplement: Calcium<br>* Administered orally<br>Dietary Supplement: Vitamin D<br>* Administered orally<br>Drug: Placebo-Oral<br>* Administered orally<br>|
| Active Comparator: Alendronate<br>10 milligrams/day alendronate orally plus SC injection placebo for 18 months. | Drug: Alendronate<br>* Administered orally<br>Dietary Supplement: Calcium<br>* Administered orally<br>Dietary Supplement: Vitamin D<br>* Administered orally<br>Drug: Placebo-SC<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change from Baseline to 18 Months in Lumbar Spine BMD |  | Baseline, 18 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change from Baseline in Lumbar Spine BMD |  | Baseline, 3 Months, 6 Months, 12 Months | 
| Percent Change from Baseline in Total Hip and Femoral Neck BMD |  | Baseline, 12 Months, 18 Months | 
| Percent Change from Baseline in Trabecular Volumetric BMD at the Lumbar Spine |  | Baseline, 6 Months, 18 Months | 
| Percent Change from Baseline in Cortical BMD at the Femoral Neck |  | Baseline, 6 Months, 18 Months | 
| Percent Change from Baseline in Trabecular BMD at the Femoral Neck |  | Baseline, 6 Months, 18 Months | 
| Percent Change from Baseline in Biochemical Marker -Serum Procollagen I C-Terminal Propeptide (PICP) |  | Baseline, 1 Month, 3 Months, 6 Months, 12 Months | 
| Percent Change from Baseline in Biochemical Marker -Serum Procollagen I N-Terminal Propeptide (PINP) |  | Baseline, 1 Month, 3 Months, 6 Months, 12 Months | 
| Percent Change from Baseline in Biochemical Marker -Bone-Specific Alkaline Phosphatase (BSAP) |  | Baseline, 1 Month, 3 Months, 6 Months, 12 Months | 
| Percent Change from Baseline in Biochemical Marker -Urinary N-Telopeptide (NTX) |  | Baseline, 1 Month, 3 Months, 6 Months, 12 Months | 
| Percentage of Participants with Nonvertebral Fractures |  | 18 Months | 
| Percentage of Participants with Clinical Fractures |  | 18 Months | 
| Change from Baseline on the Back Pain Questionnaire |  | Baseline, 3 Months, 6 Months, 18 Months |