NCT01522521

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2012

Typical duration for phase_3

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

October 2, 2015

Status Verified

October 1, 2015

Enrollment Period

2.9 years

First QC Date

January 27, 2012

Last Update Submit

October 1, 2015

Conditions

Osteoporosis

Keywords

AK156

Outcome Measures

Primary Outcomes (1)

  • New vertebral fractures

    Reduction in the incidence rate of new fragility vertebral fractures

    2 Years

Secondary Outcomes (4)

  • Vertebral fractures (worsening and new)

    2 Years

  • Clinical fractures

    2 Years

  • Bone mineral density

    2 Years

  • Bone metabolic marker

    2 Years

Study Arms (2)

1.

EXPERIMENTAL
Drug: AK156

2.

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AK156DRUG

zoledronic acid (i.v.)/year + daily calcium and vitamin D for 2 years

1.
PlaceboDRUG

placebo (i.v.)/year + daily calcium and vitamin D for 2 years

2.

Eligibility Criteria

Age65 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients diagnosed with primary osteoporosis
  • Patients who have vertebral fractures at the time of screening

You may not qualify if:

  • Patients diagnosed with secondary osteoporosis
  • Patients with a current uncontrolled medical disorder or other condition which makes the patient unsuitable for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Unknown Facility

Chiba, Chiba, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, Japan

Location

Unknown Facility

Kure, Hiroshima, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Inami-cho, Hyōgo, Japan

Location

Unknown Facility

Morioka, Iwate, Japan

Location

Unknown Facility

Kagoshima, Kagoshima-ken, Japan

Location

Unknown Facility

Yokohama, Kanagawa, Japan

Location

Unknown Facility

Kumamoto, Kumamoto, Japan

Location

Unknown Facility

Sendai, Miyagi, Japan

Location

Unknown Facility

Miyazaki, Miyazaki, Japan

Location

Unknown Facility

Matsumoto, Nagano, Japan

Location

Unknown Facility

Bungo-ōno, Oita Prefecture, Japan

Location

Unknown Facility

Tosu, Saga-ken, Japan

Location

Unknown Facility

Tokorozawa, Saitama, Japan

Location

Unknown Facility

Kikukawa, Shizuoka, Japan

Location

Unknown Facility

Oyama, Tochigi, Japan

Location

Unknown Facility

Setagaya City, Tokyo, Japan

Location

Unknown Facility

Shinagawa, Tokyo, Japan

Location

Unknown Facility

Tonami, Toyama, Japan

Location

Related Publications (3)

  • 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.

    PMID: 34247263DERIVED

  • 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.

    PMID: 31688575DERIVED

  • 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.

    PMID: 27631091DERIVED

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Asahi Kasei Pharma Corporation

    Clinical Development Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2012

First Posted

January 31, 2012

Study Start

February 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

October 2, 2015

Record last verified: 2015-10

Locations

JP(20)