Phase 3 Clinical Trial of Teriparatide in Japan

September 14, 2010 updated by: Eli Lilly and Company

Efficacy and Safety of LY333334 in Japanese Patients With Osteoporosis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • 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
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Teriparatide
20 micrograms for 104 weeks
Drug: Teriparatide
daily, subcutaneous
Other Names:
  • Forteo
  • LY333334
  • 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:
  • Forteo
  • LY333334
  • Forsteo
Drug: Placebo
daily, subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 52 Weeks
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.
Baseline to 52 Weeks
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.
Baseline to 52 Weeks
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.
Baseline to Weeks 4, 12, 24, and 52
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.
Baseline to Weeks 4, 12, 24, 52
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.
Baseline to Weeks 4, 12, 24, 52
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.
Baseline through 52 weeks
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.
Baseline through 52 Weeks
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).
Baseline, Weeks 12, 24, 36, 52
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.
Baseline, 76 Weeks, 104 Weeks
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.
Baseline, 76 Weeks, 104 Weeks
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.
Baseline, 76 Weeks, 104 Weeks
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.
Baseline, 76 Weeks, 104 Weeks
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.
Baseline, 76 Weeks, 104 Weeks
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.
Baseline, 76 Weeks, 104 Weeks
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.
Baseline, 76 Weeks, 104 Weeks
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.
Baseline through 104 Weeks
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.
Baseline Through 104 Weeks
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).
Baseline, 76 Weeks, 104 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

February 7, 2007

First Submitted That Met QC Criteria

February 7, 2007

First Posted (Estimate)

February 9, 2007

Study Record Updates

Last Update Posted (Estimate)

September 21, 2010

Last Update Submitted That Met QC Criteria

September 14, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10494
  • B3D-JE-GHDB (Other Identifier: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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