Phase 3 Clinical Trial of Teriparatide in Japan
- Registration Number
- NCT00433160
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
To evaluate the efficacy of teriparatide based on measurements of bone mineral density at lumbar spine
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 207
- Japanese patients diagnosed with osteoporosis
- Aged 55 or older
- Patients who are at high risk for fracture
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks Placebo Teriparatide Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks Teriparatide Teriparatide 20 micrograms for 104 weeks
- Primary Outcome Measures
Name Time Method Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) Baseline to 52 weeks Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.
- Secondary Outcome Measures
Name Time Method Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) Baseline to 52 Weeks 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 Baseline to 52 Weeks 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 Baseline to 52 Weeks 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) Baseline to Weeks 4, 12, 24, and 52 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) Baseline to Weeks 4, 12, 24, 52 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) Baseline to Weeks 4, 12, 24, 52 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 Baseline through 52 weeks 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 Baseline through 52 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.
Back Pain Severity Baseline, Weeks 12, 24, 36, 52 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 Baseline, 76 Weeks, 104 Weeks 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 Baseline, 76 Weeks, 104 Weeks 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 Baseline, 76 Weeks, 104 Weeks 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 Baseline, 76 Weeks, 104 Weeks 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 Baseline, 76 Weeks, 104 Weeks 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 Baseline, 76 Weeks, 104 Weeks 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 Baseline, 76 Weeks, 104 Weeks 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 Baseline through 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.
Fractures by Investigators Assessment During Entire Study Period of 104 Weeks Baseline Through 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.
Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks Baseline, 76 Weeks, 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).
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇯🇵Tottori, Japan