UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of osteoporosis treatments in patients undergoing TKA.
Acronym	The influence of the drug for the treatment of osteoporosis on the proximal tibia
Scientific Title	Evaluation of osteoporosis treatments in patients undergoing TKA.
Scientific Title:Acronym	The influence of the drug for the treatment of osteoporosis on the proximal tibia
Region	Japan

Condition
Condition	Osteoarthritis of the knee Osteoporosis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigating the influence of the drug for the osteoporosis on the tibial lateral plateau
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Bone density at lumbar spine, bone metabolism markers (PINP, ucOC, TRACP-5b), KL score, KSS, CT on knee, and density and structure of excised samples.
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Resedronate 17.5mg/week
Interventions/Control_2	Teriparatide 56.5ug/week
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	Osteoporosis patients with high risk of bone fracture who is scheduled to have either BP or Teriparatide treatment* prior to TKA. * BP (Resedronate 17.5/week) or Teriparatide 56.5ug/week is administered 3 months prior to TKA.
Key exclusion criteria	none
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Kenichiro Middle name Last name Takashiba
Organization	Medical Co. LTA Fukuoka Mirai hospital
Division name	Bone and joint center
Zip code	8130017
Address	3-5-1 Kashiiteriha Higashi-ku Fukuoka city
TEL	0926623535
Email	k-takashiba@fukuoka-mirai.jp

Public contact
Name of contact person	1st name Kenichiro Middle name Last name Takashiba
Organization	Medical Co. LTA Fukuoka Mirai hospital
Division name	Bone and joint center
Zip code	8130017
Address	3-5-1 Kashiiteriha Higashi-ku Fukuoka city
TEL	0926623535
Homepage URL
Email	k-takashiba@fukuoka-mirai.jp

Sponsor
Institute	Medical Co. LTA Fukuoka Mirai hospital
Institute
Department

Funding Source
Organization	Health Outcome Research Institute
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Hakata Clinic IRB
Address	6-18 Tenyamachi, Hakata-ku, Fukuoka
Tel	0922387701
Email	miyako-koga@lta-med.com

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 09 Month 30 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	2014 Year 07 Month 15 Day
Date of IRB	2014 Year 07 Month 18 Day
Anticipated trial start date	2014 Year 10 Month 01 Day
Last follow-up date	2022 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 09 Month 30 Day
Last modified on	2022 Year 08 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017787