UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of improving the bone density at the surrounding total knee arthroplasty by Human Parathyroid Hormone (PTH)
Title of the study (Brief title)	The effect of improving the bone density at the surrounding TKA by PTH
Region	Japan

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

Objectives
Narrative objectives1	The study that previously conducted suggested that reduced bone density of surround the specific part of artificial knee joint.It cause the fracture of that with high potentiality. This time, we investigate of improvement effect of the bone atrophy at surround the artificial knee joint by Human Parathyroid Hormone,among the patient who has osteoporosis and was post-operation of total knee arthroplasty.In addition to improvement effect on the clinical evaluation of osteoporosis or knee joint.
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Investigation of improvement effect the bone atrophy of surround the artificial knee joint by Human Parathyroid Hormone
Key secondary outcomes	Investigation of improvement effect on the clinical evaluation of osteoporosis or knee joint by Human Parathyroid Hormone

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Human Parathyroid Hormone is administered by subctaneous injection(20 microgram with single daily dosing during 2 year or 56.5 microgram with single weekly dosing during 1.5 year)
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Osteoporosis patient who is postoperative total knee arthroplasty and administered the Human Parathyroid Hormone. 2)Patient who is a subject of the present study and consented to the data provided.
Key exclusion criteria	1)Patient who is suspected of being pregnant or pregnant women 2)Patient who is difficult to communicate
Target sample size	50

Research contact person
Name of lead principal investigator	Fumio Sukesaki MD
Organization	Showa university Hospital
Division name	Orthopedics
Address	1-5-8 Hatanodai Shinagawa-ku Tokyo 142-8555
TEL	03-3784-8543
Email	tatsuyawahaha@yahoo.co.jp

Public contact
Name of contact person	Fumio Sukesaki
Organization	Showa university Hospital
Division name	Orthopedics
Address	1-5-8 Hatanodai Shinagawa-ku Tokyo 142-8555
TEL	03-3784-8543
Homepage URL
Email	tatsuyawahaha@yahoo.co.jp

Sponsor
Institute	Showa university Hospital Department of Orthopedics
Institute
Department

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

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

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 26 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 03 Month 19 Day
Anticipated trial start date	2014 Year 04 Month 04 Day
Last follow-up date	2016 Year 08 Month 07 Day
Date of closure to data entry	2016 Year 08 Month 07 Day
Date trial data considered complete	2016 Year 08 Month 07 Day
Date analysis concluded	2016 Year 08 Month 07 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results	At the time of the end for six months, it was recognized that the influence on bone metabolism with the PTH dosage in drawing blood data , but not recognized the rise in bone density of the region of interest.
Other related information

Management information
Registered date	2014 Year 05 Month 26 Day
Last modified on	2017 Year 07 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016382