UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015573
Receipt number R000018098
Scientific Title Fracture inhibitory effect verification test of osteoporosis drug for primary osteoporosis patients at high risk of fracture
Date of disclosure of the study information 2014/11/01
Last modified on 2021/06/01 11:08:23

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Basic information

Public title

Fracture inhibitory effect verification test of osteoporosis drug for primary osteoporosis patients at high risk of fracture

Acronym

A-TOP/JOINT-05

Scientific Title

Fracture inhibitory effect verification test of osteoporosis drug for primary osteoporosis patients at high risk of fracture

Scientific Title:Acronym

A-TOP/JOINT-05

Region

Japan


Condition

Condition

Osteoporosis

Classification by specialty

Medicine in general Endocrinology and Metabolism Obstetrics and Gynecology
Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The head-to-head comparison of once
weekly teriparatid and alendronate

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

Incidence of new vertebral fracture
at 72 weeks

Key secondary outcomes

Incidence of new vertebral fracture and non-vertebral fracture at 72 and 120 weeks
Incidence of new vertebral fracture
Exacerbation of vertebral fracture incidence
BMD rate of change
QOL rate of change
Bone structure analysis


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Food

Interventions/Control_1

once weekly teriparatide

Interventions/Control_2

alendronate

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

75 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

A document agreement of the clinical study participation is provided and intends for a patient meeting all the following standards
1.Primary osteoporosis
2.a Japanese patient 75 years or older
3.postmenopausal women
4.The patient that an independence walk is possible
5.The patient who satisfies any of the following
Patient with less than in bone density 60% of YAM or less than -3.3SD
The patient who has vertebral body bone fractures more than two to the fourth lumbar vertebrae from the fourth thoracic vertebra at the time of registration
Patient having a bone fracture of grade 3
The patient who has the past of the proximal thighbone bone fracture

Key exclusion criteria

1.Secondary osteoporosis
2.bone loss Disease other than osteoporosis
3.diseases that affect the strength of the vertebral body
4.hypersensitivity
5.use of contraindicated therapeutic drugs
6.severe complications such as heart disease, liver disease, renal disease
7.problem with the reliability of the interview data
8.inpatient
9.Patients treated with teriparatide in the past

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Satoshi
Middle name
Last name Mori

Organization

Seirei Hamamatsu General Hospital

Division name

chief department of Bone&Joint and Orthopaedic surgery

Zip code

4308558

Address

2-12-12Sumiyoshi,Chuo-ku,Hamamtsu,Shizuoka

TEL

053-474-2222

Email

stmori@sis.seirei.or.jp


Public contact

Name of contact person

1st name Yoji
Middle name
Last name Mitadera

Organization

Public Health Research Foundation

Division name

Comprehensive Support Project for

Zip code

1690051

Address

1-1-7Nishiwaseda,Shinjuku-ku,Tokyo,japan

TEL

03-5287-2638

Homepage URL

http://www.a-top.jp

Email

a-top@csp.or.jp


Sponsor or person

Institute

Research committee of A-TOP

Institute

Department

Personal name



Funding Source

Organization

Public Health Research Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

-

Address

-

Tel

-

Email

-


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2014 Year 11 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 09 Month 29 Day

Date of IRB

2014 Year 10 Month 06 Day

Anticipated trial start date

2014 Year 11 Month 04 Day

Last follow-up date

2020 Year 05 Month 30 Day

Date of closure to data entry

2020 Year 07 Month 31 Day

Date trial data considered complete

2020 Year 10 Month 31 Day

Date analysis concluded

2020 Year 12 Month 29 Day


Other

Other related information



Management information

Registered date

2014 Year 10 Month 31 Day

Last modified on

2021 Year 06 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018098


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name