Clinical Trial of Teriparatide in Japan

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

Teriparatide

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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
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
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
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
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
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

Outcomes

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

Full Information

NCT ID

NCT00191867

First Posted

September 12, 2005

Last Updated

November 5, 2007

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00191867

Brief Title

Clinical Trial of Teriparatide in Japan

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Completed

Study Start Date

February 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

160 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Teriparatide

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

To evaluate the safety of LY333334

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name