Status:

COMPLETED

Phase 3 Clinical Trial of Teriparatide in Japan

Lead Sponsor:

Eli Lilly and Company

Conditions:

Osteoporosis

Eligibility:

All Genders

55+ years

Phase:

PHASE3

Brief Summary

To evaluate the efficacy of teriparatide based on measurements of bone mineral density at lumbar spine

Eligibility Criteria

Inclusion

  • Japanese patients diagnosed with osteoporosis
  • Aged 55 or older
  • Patients who are at high risk for fracture

Exclusion

  • History of metabolic bone disorders other than primary osteoporosis
  • History of malignant neoplasm in the 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated.
  • Severe or chronically disabling conditions other than osteoporosis

Key Trial Info

Start Date :

January 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2009

Estimated Enrollment :

207 Patients enrolled

Trial Details

Trial ID

NCT00433160

Start Date

January 1 2007

End Date

September 1 2009

Last Update

September 21 2010

Active Locations (16)

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Page 1 of 4 (16 locations)

1

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Aichi, Japan, 454-0933

2

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Fukuoka, Japan, 811-2101

3

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Hokkaido, Japan, 070-0034

4

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Hyōgo, Japan, 655-0853