UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035653
Receipt number R000040613
Scientific Title Denosumab prevents periprosthetic bone mineral density loss in the tibial metaphysis in total knee arthroplasty
Date of disclosure of the study information 2019/01/25
Last modified on 2019/01/24 09:48:05

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Basic information

Public title

Denosumab prevents periprosthetic bone mineral density loss in the tibial metaphysis in total knee arthroplasty

Acronym

The effect of denosumab in periprosthetic bone mineral density

Scientific Title

Denosumab prevents periprosthetic bone mineral density loss in the tibial metaphysis in total knee arthroplasty

Scientific Title:Acronym

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

1st name
Middle name
Last name Atsushi Teramoto

Organization

Sapporo Medical University School of Medicine

Division name

Department of Orthopaedic Surgery

Zip code


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

1st name
Middle name
Last name Yasutaka Murahashi

Organization

Sapporo Medical Univ. School of Medicine

Division name

Department of Orthopaedic Surgery

Zip code


Address

S-1, W-16, Chuo-ku, Sapporo, 060-8543, Hokkaido, Japan

TEL

01161112111(33330)

Homepage URL


Email

yayayaya1126@yahoo.co.jp


Sponsor or person

Institute

Department of Orthopaedic Surgery, Sapporo Medical University School of Medicine

Institute

Department

Personal name



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)



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

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


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

Completed

Date of protocol fixation

2014 Year 11 Month 05 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040613


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name