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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016809
Receipt No. R000019485
Scientific Title Clinical outcomes of combination treatment of teriparatide and denosumab for patients with osteoporotic vertebral factures
Date of disclosure of the study information 2015/04/01
Last modified on 2016/06/01

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Basic information
Public title Clinical outcomes of combination treatment of teriparatide and denosumab for patients with osteoporotic vertebral factures
Acronym Clinical outcomes of combination treatment of teriparatide and denosumab for patients with osteoporotic vertebral factures
Scientific Title Clinical outcomes of combination treatment of teriparatide and denosumab for patients with osteoporotic vertebral factures
Scientific Title:Acronym Clinical outcomes of combination treatment of teriparatide and denosumab for patients with osteoporotic vertebral factures
Region
Japan

Condition
Condition osteoporotic vertebral factures
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of study was to clarify that clinical outcomes of combination treatment of teriparatide and denosumab for patients with osteoporotic vertebral factures
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes XP, ADL and QOL at 6 months after osteoporotic vertebral factures
Key secondary outcomes

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 combination treatment of teriparatide and denosumab
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients older than 65 years
and with a fresh OVF
Key exclusion criteria artificial dialysis
dementia
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motoki Iwasaki
Organization Osaka Rosai Hospital
Division name orthopaedics
Zip code
Address 1179-3 Nagasonecho, Kita-ku, Sakai 591-8025, Osaka
TEL 0722-52-3561
Email iwasaki@ort.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomiya Matsumoto
Organization Osaka Rosai Hospital
Division name orthopaedics
Zip code
Address 1179-3 Nagasonecho, Kita-ku, Sakai 591-8025, Osaka
TEL 0722-52-3561
Homepage URL
Email spap44d9@bird.ocn.ne.jp

Sponsor
Institute Osaka Rosai Hospital
Institute
Department

Funding Source
Organization Osaka Rosai Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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
2015 Year 04 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 Preinitiation
Date of protocol fixation
2015 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 16 Day
Last modified on
2016 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019485

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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