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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019338
Receipt No. R000022363
Scientific Title Clinical outcome of risedronate therapy for patients with Paget's disease of bone
Date of disclosure of the study information 2015/10/15
Last modified on 2019/10/18

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Basic information
Public title Clinical outcome of risedronate therapy for patients with Paget's disease of bone
Acronym Clinical outcome of risedronate therapy for patients with Paget's disease of bone
Scientific Title Clinical outcome of risedronate therapy for patients with Paget's disease of bone
Scientific Title:Acronym Clinical outcome of risedronate therapy for patients with Paget's disease of bone
Region
Japan

Condition
Condition Paget's disease of bone
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness of high dose resedronate for patients with Paget's disease of bone
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ALP value
Key secondary outcomes pain

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 risedronate 17.5mg
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
18 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria ALP value over normal range
Key exclusion criteria not tolerated for risedronate
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Yoshihiro
Middle name
Last name Nishida
Organization Nagoya University Hospital
Division name Orthopaedic Surgery
Zip code 4668550
Address 65-Tsurumai, Showa, Nagoya
TEL 052-741-2111
Email ynishida@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Nishida
Middle name
Last name Yoshihiro
Organization Nagoya University Hospital
Division name Orthopaedic Surgery
Zip code 466-8550
Address 65-Tsurumai, Showa, Nagoya
TEL 052-741-2111
Homepage URL
Email ynishida@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization JAPA:Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagoya University
Address Orthopaedic surgery, 65-Tsurumai
Tel 0527412111
Email ethics@med.nagoya-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 名古屋大学医学部附属病院(愛知県)

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 15 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 Open public recruiting
Date of protocol fixation
2009 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 05 Month 15 Day
Date trial data considered complete
2018 Year 09 Month 01 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 10 Month 14 Day
Last modified on
2019 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022363

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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