Phase 3 Clinical Trial of Teriparatide in Japan

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00433160
First received: February 7, 2007
Last updated: September 14, 2010
Last verified: September 2010
  Purpose

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


Condition Intervention Phase
Osteoporosis
Drug: Teriparatide
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of LY333334 in Japanese Patients With Osteoporosis

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) [ Time Frame: Baseline to 52 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 207
Study Start Date: January 2007
Study Completion Date: September 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Teriparatide
20 micrograms for 104 weeks
Drug: Teriparatide
daily, subcutaneous
Other Names:
  • LY333334
  • Forteo
  • Forsteo
Placebo Comparator: Placebo
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
Drug: Teriparatide
daily, subcutaneous
Other Names:
  • LY333334
  • Forteo
  • Forsteo
Drug: Placebo
daily, subcutaneous

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433160

Locations
Japan
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, 454-0933
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.
Fukuoka, Japan, 811-2101
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.
Hokkaido, Japan, 070-0034
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.
Hyogo, Japan, 655-0853
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.
Iwate, Japan, 020-8505
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.
Kagoshima, Japan, 890-0014
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.
Kanagawa, Japan, 231-0023
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.
Nagano, Japan, 386-0493
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.
Nagasaki, Japan, 854-0083
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.
Oita, Japan, 879-7125
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.
Osaka, Japan, 555-0032
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.
Saitama, Japan, 358-0007
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.
Shimane, Japan, 693-0021
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.
Tokushima, Japan, 770-8503
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.
Tokyo, Japan, 163-0202
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, 683-0853
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

Additional Information:
Publications:
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00433160     History of Changes
Other Study ID Numbers: 10494, B3D-JE-GHDB
Study First Received: February 7, 2007
Results First Received: August 17, 2009
Last Updated: September 14, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014