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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008610
Receipt No. R000010119
Scientific Title To clarify different effects of daily and weekly hPTH(1-34), teriparatide, administration on local and systemic bone metabolism during healing period after vertebral fracture.
Date of disclosure of the study information 2012/08/06
Last modified on 2017/10/23

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Basic information
Public title To clarify different effects of daily and weekly hPTH(1-34), teriparatide, administration on local and systemic bone metabolism during healing period after vertebral fracture.
Acronym To test different effects of daily and weekly teriparatide on local and systemic bone metabolism during fracture healing after vertebral fracture
Scientific Title To clarify different effects of daily and weekly hPTH(1-34), teriparatide, administration on local and systemic bone metabolism during healing period after vertebral fracture.
Scientific Title:Acronym To test different effects of daily and weekly teriparatide on local and systemic bone metabolism during fracture healing after vertebral fracture
Region
Japan

Condition
Condition osteoporosis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify different effects of daily and weekly hPTH(1-34), teriparatide, administration during healing period after vertebral fracture on the fracture site, pain and systemic bone turnover, and different indication of those two agents.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Bone metabolic markers
Key secondary outcomes Vertebral and femoral bone mineral density, numbers of new vertebral fractures during the study period, VAS, JOQOL, RDQ, QUEST, and bony union

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Teriparatide Acetate
Interventions/Control_2 Teriparatide (Genetical Recombination)
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
60 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Post-menopausal women of 60-y-o or above with sever osteoporosis who have a fresh vertebral fracture and understand, and literary approve to be included to this study.
#1; The fresh vertebral fracture, what occur during 2 weeks, is defined with history, physical examination and X-ray appearances and/or MRI of spine.
#2; The sever osteoporosis is diagnosed to a patient whose point is accounting for 3 or above by our appraisal standard as follow.
Point
70%YAM>BMD=/>65% 1
65%YAM>BMD=/>60% 2
60%YAM>BMD 3
New vertebral fracture 1
Using corticosteroid 1
Old vertebral fracture =1 1
Old vertebral fractures >1 2
Sever osteoporosis: total 3=/<
Key exclusion criteria 1. Patients in whom study drugs (teriparatide) are contraindicated
2. Serious renal, hepatic, or cardiac disease
3. Secondly osteoporosis
4. Patients who are considered inappropriate for enrollment by the investigator for any other reason
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinya Tanaka
Organization Saitama Medical University
Division name Department of Orthopaedic Surgery
Zip code
Address Morohongo 38, moroyamacho, Irumagun, Saitamaken, Japan
TEL 049-276-1238
Email tnk_sny@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinya Tanaka
Organization Saitama Medical University
Division name Department of Orthopaedic Surgery
Zip code
Address 350-0495, Morohongo 38, Moroyama-cho, Iruma-gun, Saitama, Japan
TEL 049-276-1238
Homepage URL
Email tnk_sny@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

Funding Source
Organization Japan Osteoporosis 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 埼玉医科大学病院(埼玉県)、埼玉医科大学かわごえクリニック(埼玉県)、小川日本赤十字病院(埼玉県)、関越病院(埼玉県)、若葉病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2012 Year 08 Month 06 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
2012 Year 06 Month 28 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 06 Day
Last follow-up date
2014 Year 03 Month 31 Day
Date of closure to data entry
2014 Year 07 Month 31 Day
Date trial data considered complete
2014 Year 07 Month 31 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 08 Month 03 Day
Last modified on
2017 Year 10 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010119

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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