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OpenTrials
Completed

NCT Number: NCT00433160

Phase 3 Clinical Trial of Teriparatide in Japan

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

Completed

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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., Aichi, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teriparatide

Drug

daily, subcutaneous

Other names: LY333334, Forteo, Forsteo

Placebo

Drug

daily, subcutaneous

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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).

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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).

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Efficacy and Safety of LY333334 in Japanese Patients With Osteoporosis

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Feb 9, 2007
Registry last updated
Sep 21, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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