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Study of AK156 in Primary Osteoporosis Patients

NCT01522521 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2015-10-02

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

AK156

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Asahi Kasei Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • Asahi Kasei Pharma Corporation · Clinical Development Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Japan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01522521 on ClinicalTrials.gov