UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Denosumab prevents periprosthetic bone mineral density loss in the tibial metaphysis in total knee arthroplasty
Title of the study (Brief title)	The effect of denosumab in periprosthetic bone mineral density
Region	Japan

Condition
Condition	Primary osteoarthritis of knee
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate whether denosumab treatment after total knee arthroplasty could prevent periprosthetic bone resorption in the patients of primary osteoarthritis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	We measure periprosthetic bone mineral density using dual energy X-ray absorptiometry after total knee arthroplasty for 12 months.
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients in the intervention group received 0.5 ug vitamin D3 (Alfacalcidol) daily and 60 mg denosumab every 6 months from the day after total knee arthroplasty for 12 months.
Interventions/Control_2	Patients in the control group received 0.5 ug active vitamin D3 (Alfacalcidol) daily from the day after total knee arthroplasty for 12 months.
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	We include only patients with osteoporosis and primary osteoarthritis of the knee.
Key exclusion criteria	We exclude patients who are undergoing revision surgery, and those who had previously taken anti-osteoporotic drugs or other medications known to influence bone mineral metabolism.
Target sample size	28

Research contact person
Name of lead principal investigator	Atsushi Teramoto
Organization	Sapporo Medical University School of Medicine
Division name	Department of Orthopaedic Surgery
Address	S-1, W-16, Chuo-ku, Sapporo, 060-8543, Hokkaido, Japan
TEL	01161112111(33330)
Email	teramoto.atsushi@gmail.com

Public contact
Name of contact person	Yasutaka Murahashi
Organization	Sapporo Medical Univ. School of Medicine
Division name	Department of Orthopaedic Surgery
Address	S-1, W-16, Chuo-ku, Sapporo, 060-8543, Hokkaido, Japan
TEL	01161112111(33330)
Homepage URL
Email	yayayaya1126@yahoo.co.jp

Sponsor
Institute	Department of Orthopaedic Surgery, Sapporo Medical University School of Medicine
Institute
Department

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

Other related organizations
Co-sponsor	None
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	札幌医科大学附属病院(北海道) Sapporo Medical University Hospital

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 05 Day
Anticipated trial start date	2014 Year 12 Month 11 Day
Last follow-up date	2018 Year 12 Month 27 Day
Date of closure to data entry	2018 Year 12 Month 27 Day
Date trial data considered complete	2018 Year 12 Month 27 Day
Date analysis concluded	2018 Year 12 Month 27 Day

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

Management information
Registered date	2019 Year 01 Month 24 Day
Last modified on	2019 Year 01 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040613