UMIN-CTR Clinical Trial

Basic information
Public title	Effects of denosumab for bone resorption in the femur after total hip arthroplasty
Acronym	Effects of denosumab for bone resorption in the femur after total hip arthroplasty
Scientific Title	Effects of denosumab for bone resorption in the femur after total hip arthroplasty
Scientific Title:Acronym	Effects of denosumab for bone resorption in the femur after total hip arthroplasty
Region	Japan

Condition
Condition	patients treated with primary total hip arthroplasty
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of denosumab for inhibition of bone resorption in the femur after total hip arthroplasty.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	DEXA of the femur
Key secondary outcomes	P1NP, TRAP5b plain radiographs of the hip joint

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	Denosumab: 60 mg once in 6 months by subcutaneous injection. Eldecalcitol: 0.75 micro g once a day orally. These 2 drugs will be continued for 2 years.
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) Male:20 years old or more, Female: menopause (2) Japanese (3) Osteoarthritis of the hip or Osteonecrosis of the hip (4) No treatment of osteoporosis (5) Independence of daily living (6) Change of bone mineral density is within 10% or decrease of bone mineral density is 10% or more between 1 year and last follow-up. (7) Patients agree to participate in this study with written informed consent.
Key exclusion criteria	(1) Severe renal failure (CCr:less than 30mL/min) (2) Hypercalcemea or hypocalcemia (3) Past history of femoral osteotomy (4) Systemic bone disease (5) Patients, who are considered to be inappropriate for this study by doctors.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yutaka Inaba
Organization	Yokohama City University
Division name	Department of Orthopaedic Surgery
Zip code
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL	045-787-2655
Email	yute0131@med.yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hyonmin Choe
Organization	Yokohama City University
Division name	Department of Orthopaedic Surgery
Zip code
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL	045-787-2655
Homepage URL
Email	hyonmin@hotmail.com

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Yokohama City University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2017 Year 07 Month 10 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	Enrolling by invitation
Date of protocol fixation	2016 Year 04 Month 07 Day
Date of IRB	2016 Year 06 Month 06 Day
Anticipated trial start date	2016 Year 06 Month 06 Day
Last follow-up date	2022 Year 07 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 07 Month 10 Day
Last modified on	2022 Year 07 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032240