Phase 3 Clinical Trial of Teriparatide in Japan

Study Overview
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Brief Summary
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To evaluate the efficacy of teriparatide based on measurements of bone mineral density at lumbar spine

Official Title
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Efficacy and Safety of LY333334 in Japanese Patients With Osteoporosis

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Teriparatide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Japanese patients diagnosed with osteoporosis Aged 55 or older Patients who are at high risk for fracture Exclusion Criteria: History of metabolic bone disorders other than primary osteoporosis History of malignant neoplasm in the 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Severe or chronically disabling conditions other than osteoporosis

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teriparatide<br>20 micrograms for 104 weeks | Drug: Teriparatide<br>* daily, subcutaneous<br>* Other names: Forsteo;|
| Placebo Comparator: Placebo<br>Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks | Drug: Teriparatide<br>* daily, subcutaneous<br>* Other names: Forsteo;Drug: Placebo<br>* daily, subcutaneous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) | Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point. | Baseline to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) | Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point. | Baseline to 52 Weeks | 
| Percent Change in Bone Mineral Density (BMD) at Total Hip | Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point. | Baseline to 52 Weeks | 
| Percent Change in Bone Mineral Density (BMD) at Femoral Neck | Percent change in bone mineral density at femoral neck from baseline to the last measurement point. | Baseline to 52 Weeks | 
| Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) | Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point. | Baseline to Weeks 4, 12, 24, and 52 | 
| Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) | Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point. | Baseline to Weeks 4, 12, 24, 52 | 
| Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) | Percent change in serum type I collagen crosslinked C-telopeptide (CTX) from baseline to the individual visits and last measurement point. | Baseline to Weeks 4, 12, 24, 52 | 
| Vertebral Fractures by Central X-ray Assessment | Number of vertebral fractures observed from Visit 1 (study entry) through Visit 19 (Week 52). All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted. | Baseline through 52 weeks | 
| Fractures by Investigators Assessment | Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be fragility if they occurred without trauma. | Baseline through 52 Weeks | 
| Back Pain Severity | Severity of back pain at baseline, individual visits and the last measurement point. Back pain was measured on a scale of 1 (none) to 4 (severe). | Baseline, Weeks 12, 24, 36, 52 | 
| Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks | Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point. | Baseline, 76 Weeks, 104 Weeks | 
| Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks | Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point. | Baseline, 76 Weeks, 104 Weeks | 
| Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks | Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point. | Baseline, 76 Weeks, 104 Weeks | 
| Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks | Percent change in bone mineral density at femoral neck from baseline to the last measurement point. | Baseline, 76 Weeks, 104 Weeks | 
| Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks | Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point. | Baseline, 76 Weeks, 104 Weeks | 
| Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks | Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point. | Baseline, 76 Weeks, 104 Weeks | 
| Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks | Percent change in serum type I collagen crosslinked C-telepeptide (CTX) from baseline to the individual visits and last measurement point. | Baseline, 76 Weeks, 104 Weeks | 
| Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks | Number of vertebral fractures observed from Visit 1 (study entry) through 104 weeks. All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted. | Baseline through 104 Weeks | 
| Fractures by Investigators Assessment During Entire Study Period of 104 Weeks | Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be fragility if they occurred without trauma. | Baseline Through 104 Weeks | 
| Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks | Severity of back pain at 76 weeks and 104 weeks. Back pain was measured on a scale of 1 (none) to 4 (severe). | Baseline, 76 Weeks, 104 Weeks |