Study of AK156 in Primary Osteoporosis Patients

This study is currently recruiting participants.
Verified January 2012 by Asahi Kasei Pharma Corporation
Sponsor:
Information provided by (Responsible Party):
Asahi Kasei Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01522521
First received: January 27, 2012
Last updated: February 6, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Osteoporosis
Drug: AK156
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Study of AK156 in Primary Osteoporosis Patients

Resource links provided by NLM:


Further study details as provided by Asahi Kasei Pharma Corporation:

Primary Outcome Measures:
  • New vertebral fractures [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    Reduction in the incidence rate of new fragility vertebral fractures


Secondary Outcome Measures:
  • Vertebral fractures (worsening and new) [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    The incidence rate of fragility vertebral fractures (worsening and new)

  • Clinical fractures [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    The incidence rate of Clinical fractures

  • Bone mineral density [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    The percent change from baseline in bone mineral density of lumbar spine and hip

  • Bone metabolic marker [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    The percent change from baseline in bone metabolic marker


Estimated Enrollment: 600
Study Start Date: February 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. Drug: AK156
zoledronic acid (i.v.)/year + daily calcium and vitamin D for 2 years
Placebo Comparator: 2. Drug: Placebo
placebo (i.v.)/year + daily calcium and vitamin D for 2 years

  Eligibility

Ages Eligible for Study:   65 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522521

Contacts
Contact: Asahi Kasei Pharma Corporation ct-info@om.asahi-kasei.co.jp

Locations
Japan
Recruiting
Kure, Hiroshima, Japan
Recruiting
Sapporo, Hokkaido, Japan
Recruiting
Inami-cho, Hyogo, Japan
Recruiting
Morioka, Iwate, Japan
Recruiting
Yokohama, Kanagawa, Japan
Recruiting
Sendai, Miyagi, Japan
Recruiting
Matsumoto, Nagano, Japan
Recruiting
Bungo-Ono, Oita, Japan
Recruiting
Tosu, Saga, Japan
Recruiting
Tokorozawa, Saitama, Japan
Recruiting
Kikukawa, Shizuoka, Japan
Recruiting
Oyama, Tochigi, Japan
Recruiting
Setagaya, Tokyo, Japan
Recruiting
Shinagawa, Tokyo, Japan
Recruiting
Tonami, Toyama, Japan
Recruiting
Chiba, Japan
Recruiting
Fukuoka, Japan
Recruiting
Kagoshima, Japan
Recruiting
Kumamoto, Japan
Recruiting
Miyazaki, Japan
Sponsors and Collaborators
Asahi Kasei Pharma Corporation
Investigators
Study Director: Asahi Kasei Pharma Corporation Clinical Development Center
  More Information

No publications provided

Responsible Party: Asahi Kasei Pharma Corporation
ClinicalTrials.gov Identifier: NCT01522521     History of Changes
Other Study ID Numbers: AK156 III-1
Study First Received: January 27, 2012
Last Updated: February 6, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Asahi Kasei Pharma Corporation:
AK156

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 17, 2014