UMIN-CTR Clinical Trial

Public title

Anti rankl project for avascular necrosis of bone

Acronym

Anti rankl project for avascular necrosis of bone

Scientific Title

Anti rankl project for avascular necrosis of bone

Scientific Title:Acronym

Anti rankl project for avascular necrosis of bone

Region

Japan

Condition

Necrosis of bone

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In this clinical trial, administration of Denosumab (Praria subcutaneous injection 60 mg) to the osteonecrosis pathology of orthopedic diseases such as femoral head necrosis, knee bone necrosis, spinal vertebral body end plate degeneration (Modic degeneration), improvement of osteonecrosis state I and II phase tests aimed at examining side effects.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

(Side effects)
Hypocalcemia, back pain, rise in gamma-GTP, hypertension, eczema, joint pain, atypical fracture, jaw bone necrosis, etc.

Key secondary outcomes

(Improvement of osteonecrosis)
CT: CT value of the bone hardened part is measured by simple CT.
MRI: Simple MRI is used to measure area of necrosis area in T1, T2 weighted images.
(Secondary Evaluation Item of Effectiveness)
Patient pain assessment

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Denosumab (Praria subcutaneous injection 60 mg)

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

Age-lower limit

20

years-old

<=

Age-upper limit

90

years-old

>=

Gender

Male and Female

Key inclusion criteria

Patients falling under all the following conditions are targeted.
1. Male, female from ages 20 to 90 at the time of acquiring consent
2. MRI exhibits femoral head necrosis, knee bone necrosis, spinal vertebral body end plate degeneration (Modic denaturation), no decay necrosis
3. No cause of necrosis
4. The presence or absence of symptoms does not matter.
5. After receiving sufficient explanation for the participation of this study, patients who gained written consent by the patient's free will with sufficient understanding
6. Preventing and treating osteoporosis Guideline that meets the diagnostic criteria for osteoporosis according to the 2015 version

Key exclusion criteria

Those who fall under any of the following conditions are not included.
1. Patient with consciousness disorder
2. Patients with severe kidney disease
(BUN 30 mg / dL or more, serum creatinine 2.0 mg / dL or more, eGFR ((ml / min / 1.73 m 2) 30 or less)
3. Patients with severe liver disease
(AST (GOT), ALT (GPT) is 100 U or more)
4. When it is judged that mental illness or psychiatric symptoms are merged and it is difficult to participate in the exam
5. Women who may be pregnant, possibly pregnant, lactating women
6. Patients who can not keep hygiene in the oral cavity (For administration of medicines, confirm the administrated state in the oral cavity according to the attachment sentence of Pralia [Precautions for use] and, if necessary, In principle, guidance is given to instruct invasive dental procedures as much as possible, but patients who can not adhere to them should be excluded from this study)
7. Other responsibilities for examination (shared) Patients judged by physicians as inappropriate as subjects

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Seiji Ohtori

Organization

Graduate School of Medicine, Chiba University

Division name

Dept. of Orthopaedic Surgery

Zip code

Address

1-8-1 Inohana Chuo-ku, Chiba city, Chiba, Japan. 260-8670

TEL

043-222-7171

Email

sohtori@faculty.chiba-u.jp

Name of contact person

1st name
Middle name
Last name	Kazuhide Inage

Organization

Graduate School of Medicine, Chiba University

Division name

Dept. of Orthopaedic Surgery

Zip code

Address

1-8-1 Inohana Chuo-ku, Chiba city, Chiba, Japan. 260-8670

TEL

043-222-7171

Homepage URL

Email

kazuhideinage@chiba-u.jp

Institute

Graduate School of Medicine, Chiba University

Institute

Department

Personal name

Organization

The Uehara Memorial Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

06

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2017

Year

06

Month

26

Day

Date of IRB

Anticipated trial start date

2017

Year

06

Month

26

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

06

Month

26

Day

Last modified on

2018

Year

06

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032011