Clinical Trial of Teriparatide in Japan

Lilly

Status and phase: Completed; Phase 2

Conditions: Osteoporosis

Treatments: Drug: Teriparatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191867

B3D-JE-GHCS

8464

Details and patient eligibility

About

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

Sex: Female

Ages: 55+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind