UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025799
Receipt No. 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 2018/04/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Makoto Osaki
Organization Nagasaki University graduate school of biomedical sciences
Division name Department of orthopaedic surgery
Zip code
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
Middle name
Last name Koh Chiba
Organization Nagasaki University Hospital
Division name Department of orthopaedic surgery
Zip code
Address 1-7-1 Sakamoto Nagasaki 852-8501
TEL 095-819-7321
Homepage URL
Email kohchiba@estate.ocn.ne.jp

Sponsor
Institute Nagasaki University Hospital Department of Orthopaedic Surgery
Institute
Department

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
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 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 No longer recruiting
Date of protocol fixation
2017 Year 01 Month 23 Day
Date of IRB
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
2018 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.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


Contact us.