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Study of AK156 in Primary Osteoporosis Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01522521
First Posted: January 31, 2012
Last Update Posted: October 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Asahi Kasei Pharma Corporation
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    Reduction in the incidence rate of new fragility vertebral fractures


Secondary Outcome Measures:
  • Vertebral fractures (worsening and new) [ Time Frame: 2 Years ]
    The incidence rate of fragility vertebral fractures (worsening and new)

  • Clinical fractures [ Time Frame: 2 Years ]
    The incidence rate of Clinical fractures

  • Bone mineral density [ Time Frame: 2 Years ]
    The percent change from baseline in bone mineral density of lumbar spine and hip

  • Bone metabolic marker [ Time Frame: 2 Years ]
    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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522521


Locations
Japan
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
Investigators
Study Director: Asahi Kasei Pharma Corporation Clinical Development Center
  More Information

Responsible Party: Asahi Kasei Pharma Corporation
ClinicalTrials.gov Identifier: NCT01522521     History of Changes
Other Study ID Numbers: AK156 III-1
First Submitted: January 27, 2012
First Posted: January 31, 2012
Last Update Posted: October 2, 2015
Last Verified: October 2015

Keywords provided by Asahi Kasei Pharma Corporation:
AK156

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