UMIN-CTR Clinical Trial

Basic information
Public title	Effect of once-weekly teriparatide for bone metabolism in praimary osteoprosis patients.
Acronym	Effect of once-weekly teriparatide for bone metabolism.
Scientific Title	Effect of once-weekly teriparatide for bone metabolism in praimary osteoprosis patients.
Scientific Title:Acronym	Effect of once-weekly teriparatide for bone metabolism.
Region	Japan

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

Objectives
Narrative objectives1	Effect of once-weekly teriparatide for bone metabolism.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in the serum sclerostin concentration during the 18-month treatment.
Key secondary outcomes	Relationship between change of BMD and sclerostin during the 18-month treatment.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Treatment with once-weekly teriparatide was investigated change of BMD and change of serum sclerostine concentration during 18 months.Bone metabolism markers are measured before treatment, 1, 3, 6, 12 months and 18 months after treatment. BMD and whole spine Xp are assessed before treatment, 12 months and 18 months.
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	60 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	Osteoporosis was diagnosed by BMD in less than 70% of the young adult mean (YAM) in the Japanese population or the presence of fragility fractures and BMD in less than 80% of YAM.
Key exclusion criteria	Patients who are already have treated for osteporosis. Rheumatoid arthritis, dialysis patients and high vaule of PTH patients.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masao Akagi
Organization	Kindai University Hospital
Division name	Orthopaedic surgery
Zip code
Address	377-2 Ohno-higashi, Osaka-Sayama Osaka
TEL	072-366-0221
Email	tikeda@med.kindai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Terumasa Ikeda
Organization	Kindai University Hospital
Division name	Orthopaedic surgery
Zip code
Address	377-2 Ohno-higashi, Osaka-Sayama Osaka
TEL	072-366-0221
Homepage URL
Email	tikeda@med.kindai.ac.jp

Sponsor
Institute	Kindai University Hospital Department of Orthopaedic surgery
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
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	2018 Year 06 Month 28 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	Terminated
Date of protocol fixation	2013 Year 07 Month 09 Day
Date of IRB	2013 Year 05 Month 31 Day
Anticipated trial start date	2013 Year 07 Month 09 Day
Last follow-up date	2019 Year 06 Month 30 Day
Date of closure to data entry	2019 Year 11 Month 30 Day
Date trial data considered complete	2019 Year 11 Month 30 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 04 Month 03 Day
Last modified on	2020 Year 08 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036609