Phase 3 Clinical Trial of Teriparatide in Japan

Lilly

Status and phase: Completed; Phase 3

Conditions: Osteoporosis

Treatments: Drug: Teriparatide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00433160

10494

B3D-JE-GHDB (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 207 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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207 participants in 2 patient groups, including a placebo group

Teriparatide

Experimental group

Description:

20 micrograms for 104 weeks

Treatment:

Drug: Teriparatide

Placebo

Placebo Comparator group

Description:

Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks

Treatment:

Drug: Placebo

Drug: Teriparatide