UMIN-CTR Clinical Trial

Basic information
Public title	Effect of once-weekly teriparatide for bone metabolism in primary osteoprosis patients.
Acronym	Changes in markers by Weekly-Teriparatide.
Scientific Title	Effect of once-weekly teriparatide for bone metabolism in primary osteoprosis patients.
Scientific Title:Acronym	Changes in markers by Weekly-Teriparatide.
Region	Japan

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

Objectives
Narrative objectives1	Observe the relationship between bone metabolism marker change and bone density by treatment with teriparatide once a week.
Basic objectives2	Others
Basic objectives -Others	Bone metabolism markers measure P1NP, TRAP-5b, osteocalcin, sclerostin. Bone density measures femur neck and lumbar spine.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Observation of bone density and bone metabolism marker by treatment with Teriparatide during 18 months of treatment. Bone metabolism markers measure P1NP, TRAP-5b, osteocalcin, sclerostin. Bone density measures femur neck and lumbar spine.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	89 years-old >=
Gender	Male and Female
Key inclusion criteria	Men and women with YAM 70 percentage or less with value of bone mineral density. Osteoporotic fracture has occurred in men and women with YAM less than 80 percentage in BMD.
Key exclusion criteria	Patients with diabetes, rheumatoid arthritis,respiratory,endocrinological and other disease and drug use that may affect bone metabolism were excluded.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Terumasa Middle name Last name Ikeda
Organization	Kindai University Hospital
Division name	Orthopaedic surgery
Zip code	589-8511
Address	377-2,Ohono-Higashi Osaka-Sayama city Osaka
TEL	0723660221
Email	tikeda@med.kindai.ac.jp

Public contact
Name of contact person	1st name Terumasa Middle name Last name Ikeda
Organization	Kindai University Hospital
Division name	Orthopaedic surgery
Zip code	589-8511
Address	377-2,Ohono-Higashi Osaka-Sayama city Osaka
TEL	0723660221
Homepage URL	https://www.med.kindai.ac.jp/ortho/
Email	tikeda@med.kindai.ac.jp

Sponsor
Institute	Kindai University Hospital, Department of Orthopaedic surgery
Institute
Department

Funding Source
Organization	None
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	Institutional Review Board of Kindai University Hospital
Address	377-2 Ohno-higashi Osaka-sayama city
Tel	0723660221
Email	zizen@med.kindai.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

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 23 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	2013 Year 07 Month 09 Day
Date of IRB	2013 Year 05 Month 31 Day
Anticipated trial start date	2013 Year 07 Month 31 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry	2020 Year 07 Month 26 Day
Date trial data considered complete	2020 Year 07 Month 26 Day
Date analysis concluded	2020 Year 08 Month 31 Day

Other
Other related information	There is no special information.

Management information
Registered date	2018 Year 06 Month 23 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=R000037768