Clinical Trial of Teriparatide in Japan

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00191867

Enrollment

160

Registered

2005-09-19

Start date

2005-02-28

Completion date

2006-03-31

Last updated

2007-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Brief summary

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

Interventions

DRUGTeriparatide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

55 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
To evaluate the safety of LY333334	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026