Study of AK156 in Primary Osteoporosis Patients

This study has been completed.
Information provided by (Responsible Party):
Asahi Kasei Pharma Corporation Identifier:
First received: January 27, 2012
Last updated: October 1, 2015
Last verified: October 2015
The purpose of this study is to investigate the efficacy and safety of AK156 in Japanese patients with primary osteoporosis.

Condition Intervention Phase
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
Study Completion Date: January 2015
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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01522521

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

No publications provided

Responsible Party: Asahi Kasei Pharma Corporation Identifier: NCT01522521     History of Changes
Other Study ID Numbers: AK156 III-1
Study First Received: January 27, 2012
Last Updated: October 1, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Asahi Kasei Pharma Corporation:

Additional relevant MeSH terms:
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases processed this record on November 24, 2015