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Study of AK156 in Primary Osteoporosis Patients

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. Identifier: NCT01522521
Recruitment Status : Completed
First Posted : January 31, 2012
Last Update Posted : October 2, 2015
Information provided by (Responsible Party):
Asahi Kasei Pharma Corporation

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

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: AK156 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
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
Study Start Date : February 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. New vertebral fractures [ Time Frame: 2 Years ]
    Reduction in the incidence rate of new fragility vertebral fractures

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

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

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

  4. Bone metabolic marker [ Time Frame: 2 Years ]
    The percent change from baseline in bone metabolic marker

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years to 89 Years   (Older Adult)
Sexes Eligible for Study:   All
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

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 identifier (NCT number): NCT01522521

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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
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Study Director: Asahi Kasei Pharma Corporation Clinical Development Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Asahi Kasei Pharma Corporation Identifier: NCT01522521    
Other Study ID Numbers: AK156 III-1
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: October 2015
Keywords provided by Asahi Kasei Pharma Corporation:
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases