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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

November 5, 2007

Start Date ^ICMJE

February 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

To assess the dose response of LY333334 with the percent change from baseline in lumbar spine mineral density at endpoint

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00191867 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate the safety of LY333334

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Clinical Trial of Teriparatide in Japan

Official Title ^ICMJE

Assessment of Dose Response of LY333334 in Japanese Postmenopausal Women With Osteoporosis

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Osteoporosis

Intervention ^ICMJE

Drug: Teriparatide

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

160

Completion Date

March 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

55 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00191867

Other Study ID Numbers ^ICMJE

8464, B3D-JE-GHCS

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Eli Lilly and Company

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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