UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025799
Receipt number R000029671
Scientific Title Effects of monthly injected ibandronate on bone mineral density and microstructure in patients with primary osteoporosis after teriparatide treatment.
Date of disclosure of the study information 2017/01/26
Last modified on 2020/07/31 12:28:34

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Basic information

Public title

Effects of monthly injected ibandronate on bone mineral density and microstructure in patients with primary osteoporosis after teriparatide treatment.

Acronym

Effects of injected ibandronate with primary osteoporosis after teriparatide treatment.
MONUMENT Study

Scientific Title

Effects of monthly injected ibandronate on bone mineral density and microstructure in patients with primary osteoporosis after teriparatide treatment.

Scientific Title:Acronym

Effects of injected ibandronate with primary osteoporosis after teriparatide treatment.
MONUMENT Study

Region

Japan


Condition

Condition

Primary osteoporosis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigate the effects of ibandronate with primary osteoporosis after teriparatide treatment.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Changing rates of bone mineral density from start to 12months after.


Key secondary outcomes

1)Changing rates of bone mineral density of lumbar from start to 6 months after.
2)Areal bone mineral density of femur and distal radius,Changing rates of SOS in Calcaneus,Incidences of vertebral fracture,Meaturemenst of Bone turnover markers,Changing rates of Visual Analog Scale,Microarchitectures of cotical bone and cancellous bone,Changing rates of predictive bone stiffness,Changinn rates of femur morphology.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

monthly injected ibandronate

Interventions/Control_2


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

55 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

1 Primary osteoporosis patients received teriparatide 12months or more.
2 The patients who are able to receive ivandronate within 8weeks from teriparatide treatments.
3 Age:55 years and over
4 Gender:female
5 Out patients
6 Patients who agree with the documents.

Key exclusion criteria

1 Patients with a history of critical heart disease, hepatic disease, kidney disease, diabetes mellitus, cancer, endcrine disease, metabolic disease, and secondary osteoporosis.
2 Patients taking steroids more than 5mg, and drugs affecting bone metabolism.
3 Patients with a history of allergy to ibandronate or bisphosphonate and hypocalcemia.
4 Patients with a history of Participation in clinical trials.
5 More than 3 vertebral fractures between L1 toL4.
6 Patients judged inappropriate by author.

Target sample size

66


Research contact person

Name of lead principal investigator

1st name Makoto
Middle name
Last name Osaki

Organization

Nagasaki University graduate school of biomedical sciences

Division name

Department of orthopaedic surgery

Zip code

852-8501

Address

1-7-1 Sakamoto Nagasaki 852-8501

TEL

095-819-7321

Email

mosaki@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name Ko
Middle name
Last name Chiba

Organization

Nagasaki University Hospital

Division name

Department of orthopaedic surgery

Zip code

852-8501

Address

1-7-1 Sakamoto Nagasaki 852-8501

TEL

095-819-7321

Homepage URL


Email

kohchiba@estate.ocn.ne.jp


Sponsor or person

Institute

Nagasaki University Hospital Department of Orthopaedic Surgery

Institute

Department

Personal name



Funding Source

Organization

Chugai Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagasaki University Clinical Research Review Board

Address

1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken

Tel

095-819-7905

Email

gaibushikin@ml.nagasaki-u.ac.jp


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

長崎大学病院(長崎県) Nagasaki University Hospital


Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 26 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

2017 Year 01 Month 23 Day

Date of IRB

2017 Year 01 Month 24 Day

Anticipated trial start date

2017 Year 02 Month 01 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2019 Year 03 Month 31 Day

Date trial data considered complete

2019 Year 03 Month 31 Day

Date analysis concluded

2019 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 01 Month 23 Day

Last modified on

2020 Year 07 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029671


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name