UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the efficacy of teriparatide for distal radial fracture repair after plate fixation in osteoporotic patients:A prospective randomized control study.
Title of the study (Brief title)	Evaluation of the efficacy of teriparatide for fracture repair.
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to evaluate the effectiveness of teriparatide for acceleration of fracture repair in osteoporotic patient with distal radial fractures.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Primary outcome is the comparison of the percent chage of bone mineral density (BMD)of the fracture site as measured by dual-energy x-ray absorptiometry(DEXA)with or without teriparatide administration from baseline to 24 weeks after surgery.
Key secondary outcomes	Secondary outcome is the comparison of the percent change in markers of bone formation and resorption with or without teriparatide administration from baseline to 24 weeks after surgery.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Teriparatide 20 microg is administrated subcutaneously once daily for 24 weeks.
Interventions/Control_2	Active vitamine D3 1.0 microg is orally administrated once daily for 24 weeks.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Distal radial fracture with surgical treatment 2)Gender:any gender 3)Age:any ages but correspond with diagnostic criteria for primary osteoporosis 4)Cases who have ability to consent to the study 5)case expected to attend a hospital regularly as planned
Key exclusion criteria	1)Primary malignant bone tumors or bone metastasis 2)Metabolic bone disease except primary osteoporosis 3)Under medication for osteoporosis(bisphosphonates, teriparatide, or SERM ) 4)Under medication of steroid 5)Hypercalcemia 6)Suspection of metal allergy 7)Dementia, Schizophrenia, Panic disorder and other diseases that may have affect the evaluation or obstruct obtaining consent
Target sample size	20

Research contact person
Name of lead principal investigator	Hirohiko Ota
Organization	Yokohama City University Medical Center
Division name	Orthopaedics
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Email	ota_1080@yokohama-cu.ac.jp

Public contact
Name of contact person	Hirohiko Ota
Organization	Yokohama City University Medical Center
Division name	Orthopaedics
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Homepage URL
Email	ota_1080@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	JAPAN

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

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	横浜市立大学附属市民総合医療センター（神奈川県）

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 06 Month 25 Day
Anticipated trial start date	2015 Year 01 Month 01 Day
Last follow-up date	2016 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 12 Month 10 Day
Last modified on	2019 Year 02 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018510