Clinical Trial of Teriparatide in Japan

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191867
First received: September 12, 2005
Last updated: November 5, 2007
Last verified: November 2007
  Purpose

The purpose of this study is to assess the Efficacy and Safety of Teriparatide in Japanese Postmenopausal Women with Osteoporosis.


Condition Intervention Phase
Osteoporosis
Drug: Teriparatide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Assessment of Dose Response of LY333334 in Japanese Postmenopausal Women With Osteoporosis

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To assess the dose response of LY333334 with the percent change from baseline in lumbar spine mineral density at endpoint

Secondary Outcome Measures:
  • To evaluate the safety of LY333334

Estimated Enrollment: 160
Study Start Date: February 2005
Study Completion Date: March 2006
  Eligibility

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

Inclusion Criteria:

  • Japanese women with primary osteoporosis
  • Postmenopausal women aged at least 55 years
  • Patients with a high risk for fracture

Exclusion Criteria:

  • History of metabolic bone disorders other than osteoporosis
  • History of any secondary causes of osteoporosis
  • History of malignant neoplasm within the last 5 years except for 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: NCT00191867

Locations
Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Hiroshima, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Hyogo, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Kagoshima, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Nagano, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Osaka, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Tokyo, Japan
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:
No publications provided

ClinicalTrials.gov Identifier: NCT00191867     History of Changes
Other Study ID Numbers: 8464, B3D-JE-GHCS
Study First Received: September 12, 2005
Last Updated: November 5, 2007
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 July 22, 2014