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Study of AK156 in Primary Osteoporosis Patients

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
AK156
Placebo
Sponsored by
Asahi Kasei Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring AK156

Eligibility Criteria

65 Years - 89 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1.

2.

Arm Description

Outcomes

Primary Outcome Measures

New vertebral fractures
Reduction in the incidence rate of new fragility vertebral fractures

Secondary Outcome Measures

Vertebral fractures (worsening and new)
The incidence rate of fragility vertebral fractures (worsening and new)
Clinical fractures
The incidence rate of Clinical fractures
Bone mineral density
The percent change from baseline in bone mineral density of lumbar spine and hip
Bone metabolic marker
The percent change from baseline in bone metabolic marker

Full Information

First Posted
January 27, 2012
Last Updated
October 1, 2015
Sponsor
Asahi Kasei Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01522521
Brief Title
Study of AK156 in Primary Osteoporosis Patients
Official Title
Phase 3 Study of AK156 in Primary Osteoporosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asahi Kasei Pharma Corporation

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
AK156

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1.
Arm Type
Experimental
Arm Title
2.
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AK156
Intervention Description
zoledronic acid (i.v.)/year + daily calcium and vitamin D for 2 years
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo (i.v.)/year + daily calcium and vitamin D for 2 years
Primary Outcome Measure Information:
Title
New vertebral fractures
Description
Reduction in the incidence rate of new fragility vertebral fractures
Time Frame
2 Years
Secondary Outcome Measure Information:
Title
Vertebral fractures (worsening and new)
Description
The incidence rate of fragility vertebral fractures (worsening and new)
Time Frame
2 Years
Title
Clinical fractures
Description
The incidence rate of Clinical fractures
Time Frame
2 Years
Title
Bone mineral density
Description
The percent change from baseline in bone mineral density of lumbar spine and hip
Time Frame
2 Years
Title
Bone metabolic marker
Description
The percent change from baseline in bone metabolic marker
Time Frame
2 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asahi Kasei Pharma Corporation
Organizational Affiliation
Clinical Development Center
Official's Role
Study Director
Facility Information:
City
Kure
State/Province
Hiroshima
Country
Japan
City
Sapporo
State/Province
Hokkaido
Country
Japan
City
Inami-cho
State/Province
Hyogo
Country
Japan
City
Morioka
State/Province
Iwate
Country
Japan
City
Yokohama
State/Province
Kanagawa
Country
Japan
City
Sendai
State/Province
Miyagi
Country
Japan
City
Matsumoto
State/Province
Nagano
Country
Japan
City
Bungo-Ono
State/Province
Oita
Country
Japan
City
Tosu
State/Province
Saga
Country
Japan
City
Tokorozawa
State/Province
Saitama
Country
Japan
City
Kikukawa
State/Province
Shizuoka
Country
Japan
City
Oyama
State/Province
Tochigi
Country
Japan
City
Setagaya
State/Province
Tokyo
Country
Japan
City
Shinagawa
State/Province
Tokyo
Country
Japan
City
Tonami
State/Province
Toyama
Country
Japan
City
Chiba
Country
Japan
City
Fukuoka
Country
Japan
City
Kagoshima
Country
Japan
City
Kumamoto
Country
Japan
City
Miyazaki
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
34247263
Citation
Shiraki M, Kuroda T, Takeuchi Y, Sugimoto T, Tanaka S, Suzuki H, Hiraishi K, Nakamura T. Acute Phase Reactions After Intravenous Infusion of Zoledronic Acid in Japanese Patients with Osteoporosis: Sub-analyses of the Phase III ZONE Study. Calcif Tissue Int. 2021 Dec;109(6):666-674. doi: 10.1007/s00223-021-00884-7. Epub 2021 Jul 10.
Results Reference
derived
PubMed Identifier
31688575
Citation
Taguchi A, Shiraki M, Tanaka S, Ohshige H, Nakamura T. Improved periodontal disease and prevention of tooth loss in osteoporosis patients receiving once-yearly zoledronic acid: a randomized clinical trial. Menopause. 2019 Nov;26(11):1277-1283. doi: 10.1097/GME.0000000000001393.
Results Reference
derived
PubMed Identifier
27631091
Citation
Nakamura T, Fukunaga M, Nakano T, Kishimoto H, Ito M, Hagino H, Sone T, Taguchi A, Tanaka S, Ohashi M, Ota Y, Shiraki M. Efficacy and safety of once-yearly zoledronic acid in Japanese patients with primary osteoporosis: two-year results from a randomized placebo-controlled double-blind study (ZOledroNate treatment in Efficacy to osteoporosis; ZONE study). Osteoporos Int. 2017 Jan;28(1):389-398. doi: 10.1007/s00198-016-3736-y. Epub 2016 Sep 8.
Results Reference
derived

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Study of AK156 in Primary Osteoporosis Patients

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