Study of AK156 in Primary Osteoporosis Patients

Asahi Kasei Pharma Corporation600 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

600

Conditions

Osteoporosis

Interventions

AK156DRUG

zoledronic acid (i.v.)/year + daily calcium and vitamin D for 2 years

PlaceboDRUG

placebo (i.v.)/year + daily calcium and vitamin D for 2 years

Eligibility

Sex: ALLMin age: 65 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Locations (20)

Unnamed facility

Chiba, Chiba, Japan

Unnamed facility

Fukuoka, Fukuoka, Japan

Unnamed facility

Kure, Hiroshima, Japan

Outcomes

Primary Outcomes

New vertebral fractures

Reduction in the incidence rate of new fragility vertebral fractures

Time frame: 2 Years

Secondary Outcomes

Vertebral fractures (worsening and new)

The incidence rate of fragility vertebral fractures (worsening and new)

Time frame: 2 Years

Clinical fractures

The incidence rate of Clinical fractures

Time frame: 2 Years

Bone mineral density

The percent change from baseline in bone mineral density of lumbar spine and hip

Time frame: 2 Years

Bone metabolic marker

The percent change from baseline in bone metabolic marker

Time frame: 2 Years

Data from ClinicalTrials.gov

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