Clinical Trial of Teriparatide in Japan - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00191867

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 II

MedlinePlus related topics: Osteoporosis

Drug Information available for: Teriparatide Teriparatide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Assessment of Dose Response of LY333334 in Japanese Postmenopausal Women With Osteoporosis

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

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
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
Tokyo, 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
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
Osaka, 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

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Study ID Numbers:	8464, B3D-JE-GHCS
Study First Received:	September 12, 2005
Last Updated:	November 5, 2007
ClinicalTrials.gov Identifier:	NCT00191867
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Musculoskeletal Diseases
Teriparatide
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:

Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009