Phase 3 Clinical Trial of Teriparatide in Japan

• Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) [ Time Frame: Baseline to 52 Weeks ] [ Designated as safety issue: No ]
  Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.
• Percent Change in Bone Mineral Density (BMD) at Total Hip [ Time Frame: Baseline to 52 Weeks ] [ Designated as safety issue: No ]
  Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.
• Percent Change in Bone Mineral Density (BMD) at Femoral Neck [ Time Frame: Baseline to 52 Weeks ] [ Designated as safety issue: No ]
  Percent change in bone mineral density at femoral neck from baseline to the last measurement point.
• Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) [ Time Frame: Baseline to Weeks 4, 12, 24, and 52 ] [ Designated as safety issue: No ]
  Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.
• Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) [ Time Frame: Baseline to Weeks 4, 12, 24, 52 ] [ Designated as safety issue: No ]
  Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.
• Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) [ Time Frame: Baseline to Weeks 4, 12, 24, 52 ] [ Designated as safety issue: No ]
  Percent change in serum type I collagen crosslinked C-telopeptide (CTX) from baseline to the individual visits and last measurement point.
• Vertebral Fractures by Central X-ray Assessment [ Time Frame: Baseline through 52 weeks ] [ Designated as safety issue: No ]
  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.
• Fractures by Investigators Assessment [ Time Frame: Baseline through 52 Weeks ] [ Designated as safety issue: No ]
  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.
• Back Pain Severity [ Time Frame: Baseline, Weeks 12, 24, 36, 52 ] [ Designated as safety issue: No ]
  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).
• Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks [ Time Frame: Baseline, 76 Weeks, 104 Weeks ] [ Designated as safety issue: No ]
  Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.
• Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks [ Time Frame: Baseline, 76 Weeks, 104 Weeks ] [ Designated as safety issue: No ]
  Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.
• Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks [ Time Frame: Baseline, 76 Weeks, 104 Weeks ] [ Designated as safety issue: No ]
  Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.
• Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks [ Time Frame: Baseline, 76 Weeks, 104 Weeks ] [ Designated as safety issue: No ]
  Percent change in bone mineral density at femoral neck from baseline to the last measurement point.
• 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 [ Time Frame: Baseline, 76 Weeks, 104 Weeks ] [ Designated as safety issue: No ]
  Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.
• Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks [ Time Frame: Baseline, 76 Weeks, 104 Weeks ] [ Designated as safety issue: No ]
  Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.
• 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 [ Time Frame: Baseline, 76 Weeks, 104 Weeks ] [ Designated as safety issue: No ]
  Percent change in serum type I collagen crosslinked C-telepeptide (CTX) from baseline to the individual visits and last measurement point.
• Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks [ Time Frame: Baseline through 104 Weeks ] [ Designated as safety issue: No ]
  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.
• Fractures by Investigators Assessment During Entire Study Period of 104 Weeks [ Time Frame: Baseline Through 104 Weeks ] [ Designated as safety issue: No ]
  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.
• Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks [ Time Frame: Baseline, 76 Weeks, 104 Weeks ] [ Designated as safety issue: No ]
  Severity of back pain at 76 weeks and 104 weeks. Back pain was measured on a scale of 1 (none) to 4 (severe).

• To evaluate the safety of teriparatide
• To evaluate the efficacy of teriparatide on biochemical markers
• To evaluate the efficacy of teriparatide on BMD at entire proximal femur (total hip) and femoral neck

To evaluate the efficacy of teriparatide based on measurements of bone mineral density at lumbar spine

• Drug: Teriparatide
  daily, subcutaneous
  Other Names:

  • LY333334
  • Forteo
  • Forsteo
• Drug: Placebo
  daily, subcutaneous

• Experimental: Teriparatide
  20 micrograms for 104 weeks
  Intervention: Drug: Teriparatide
• Placebo Comparator: Placebo
  Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
  Interventions:

  • Drug: Teriparatide
  • Drug: Placebo

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