Study of AK156 in Primary Osteoporosis Patients

Asahi Kasei Medical

Status and phase: Completed; Phase 3

Conditions: Osteoporosis

Treatments: Drug: AK156; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01522521

AK156 III-1

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy and safety of AK156 in Japanese patients with primary osteoporosis.

Enrollment: 600 estimated patients

Sex: All

Ages: 65 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with primary osteoporosis
• Patients who have vertebral fractures at the time of screening

Exclusion criteria

• Patients diagnosed with secondary osteoporosis
• Patients with a current uncontrolled medical disorder or other condition which makes the patient unsuitable for the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups, including a placebo group

1.

Experimental group

Treatment:

Drug: AK156

2.

Placebo Comparator group

Treatment:

Drug: Placebo