Study of AK156 in Primary Osteoporosis Patients

Phase 3

Completed

• Conditions: Osteoporosis
• Interventions: Drug: AK156; Drug: Placebo

• Registration Number: NCT01522521
• Lead Sponsor: Asahi Kasei Pharma Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-27
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-01-31
• Study Start: 2012-02
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-01
• Last Update Posted: 2015-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1.	AK156	-
2.	Placebo	-

Primary Outcome Measures

Name	Time	Method
New vertebral fractures	2 Years	Reduction in the incidence rate of new fragility vertebral fractures

Secondary Outcome Measures

Name	Time	Method
Clinical fractures	2 Years	The incidence rate of Clinical fractures
Vertebral fractures (worsening and new)	2 Years	The incidence rate of fragility vertebral fractures (worsening and new)
Bone mineral density	2 Years	The percent change from baseline in bone mineral density of lumbar spine and hip
Bone metabolic marker	2 Years	The percent change from baseline in bone metabolic marker