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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bone Diseases, Metabolic
Musculoskeletal Diseases
Teriparatide
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014