Phase 3 Clinical Trial of Teriparatide in Japan

Overview

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

Full Title of Study: “Efficacy and Safety of LY333334 in Japanese Patients With Osteoporosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2008

Interventions

  • Drug: Teriparatide
    • daily, subcutaneous
  • Drug: Placebo
    • daily, subcutaneous

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eli Lilly and Company
  • Provider of Information About this Clinical Study
    • Chief Medical Officer, Eli Lilly
  • Overall Official(s)
    • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon – Fri 9 AM – 5 PM Eastern time (UTC/GMT – 5 hours, EST), Study Director, Eli Lilly and Company

Citations Reporting on Results

Miyauchi A, Matsumoto T, Sugimoto T, Tsujimoto M, Warner MR, Nakamura T. Effects of teriparatide on bone mineral density and bone turnover markers in Japanese subjects with osteoporosis at high risk of fracture in a 24-month clinical study: 12-month, randomized, placebo-controlled, double-blind and 12-month open-label phases. Bone. 2010 Sep;47(3):493-502. doi: 10.1016/j.bone.2010.05.022. Epub 2010 May 24.

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