Clinical Trial of Teriparatide in Japan

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

Completed

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

55 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teriparatide

Drug

Primary outcomes

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

Secondary outcomes

To evaluate the safety of LY333334

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start: 2005
Study completion: 2006
First posted: Sep 19, 2005
Registry last updated: Nov 6, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed