UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019874
Receipt number R000022923
Scientific Title The Effect of Rsedronate and Denosumab on Periprosthetic Bone Remodeling Following Total Hip Arthroplasty
Date of disclosure of the study information 2015/11/20
Last modified on 2020/12/22 09:44:39

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Basic information

Public title

The Effect of Rsedronate and Denosumab on Periprosthetic Bone Remodeling Following Total Hip Arthroplasty

Acronym

Prevention of stress shielding with risedoronate and denosumab

Scientific Title

The Effect of Rsedronate and Denosumab on Periprosthetic Bone Remodeling Following Total Hip Arthroplasty

Scientific Title:Acronym

Prevention of stress shielding with risedoronate and denosumab

Region

Japan


Condition

Condition

Osteoarthritis of the hip

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy of Rsedronate and Denosumab on Periprosthetic Bone Remodeling Following Total Hip Arthroplasty

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

The percentage change in periprosthetic bone mineral density

Key secondary outcomes

The change in bone mineral density of the vertebra, The percentage change in bone metabolic markers of resorption and formation, Harris Hip Score, Periprosthetic X-ray change


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

subcutaneous injection denosumab, 60mg every 6 months use for 2 years

Interventions/Control_2

oral risedronate, 17.5mg once weekly, use for 2 years

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

60 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

1) Osteoarthritis of the hip
2) Young Adult Mean< 80% / Proximal femur or Lumbar vertebra

Key exclusion criteria

1) oral Bisphosphonate therapy for more than 3 years
2) oral Bisphosphonate therapy within 6 months prior to the study enrollment
3) oral Bisphosphonate therapy for more than 2 weeks between 6 months and 3 years prior to the study enrollment
4) intravenous Bisphosphonate therapy within 5 years prior to the study enrollment
5) Parathyroid hormone therapy within 6 weeks prior to the study enrollment
6) A history of Osteotomy
7) sever renal dysfunction (GFR< 30)
8) sever liver dysfunction
9) malignant tumor
10) hypocalcemia, hypokalemia
11) A history ofesophagostenosis, esophageal achalasia
12) A history of hyperparathyroidism
13) glucocorticoids therapy
14) pregnant woman
15) The patients should be excluded, who have poor medical compliance, drug-induced allergy, etc.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Kazuo
Middle name
Last name Hirakawa

Organization

Shonan Kamakura Joint Reconstruction Center

Division name

Department of Orthopedic

Zip code

247-0061

Address

5-4-17 Dai,Kamakura,Kanagawa

TEL

0466-47-2377

Email

mail@skjrc.jp


Public contact

Name of contact person

1st name Nariaki
Middle name
Last name Nakura

Organization

Shonan Kamakura Joint Reconstruction Center

Division name

Department of Orthopedic

Zip code

247-0061

Address

5-4-17 Dai, Kamakura, Kanagawa

TEL

0466-47-2377

Homepage URL


Email

izumi.kokubun@tokushukai.jp


Sponsor or person

Institute

Shonan Kamakura Joint Reconstruction Center

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)

None


IRB Contact (For public release)

Organization

Mirai Iryo Research Center

Address

1-8-7, Koji-machi, Chiyoda-ku, Tokyo 102-0083, Japan

Tel

0332634801

Email

mirai-ec1@mirai-iryo.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

医療法人沖縄徳洲会 湘南鎌倉人工関節センター
(Shonan Kamakura Joint Reconstruction Center)


Other administrative information

Date of disclosure of the study information

2015 Year 11 Month 20 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

2015 Year 09 Month 15 Day

Date of IRB

2015 Year 09 Month 15 Day

Anticipated trial start date

2015 Year 11 Month 24 Day

Last follow-up date

2020 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 11 Month 20 Day

Last modified on

2020 Year 12 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022923


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name