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

September 12, 2005
November 5, 2007
February 2005
Not Provided
To assess the dose response of LY333334 with the percent change from baseline in lumbar spine mineral density at endpoint
Not Provided
Complete list of historical versions of study NCT00191867 on ClinicalTrials.gov Archive Site
To evaluate the safety of LY333334
Not Provided
Not Provided
Not Provided
 
Clinical Trial of Teriparatide in Japan
Assessment of Dose Response of LY333334 in Japanese Postmenopausal Women With Osteoporosis

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Osteoporosis
Drug: Teriparatide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
March 2006
Not Provided

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
Female
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00191867
8464, B3D-JE-GHCS
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
November 2007

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