UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037240
Receipt number R000042467
Scientific Title Evaluation of the efficacy of romosozumab for glucocorticoid-induced osteoporosis in long-term glucocorticoid administration patients
Date of disclosure of the study information 2019/07/07
Last modified on 2019/07/03 00:34:52

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Basic information

Public title

Evaluation of the efficacy of romosozumab for glucocorticoid-induced osteoporosis in long-term glucocorticoid administration patients

Acronym

Evaluation of the efficacy of romosozumab for glucocorticoid-induced osteoporosis in long-term glucocorticoid administration patients

Scientific Title

Evaluation of the efficacy of romosozumab for glucocorticoid-induced osteoporosis in long-term glucocorticoid administration patients

Scientific Title:Acronym

Evaluation of the efficacy of romosozumab for glucocorticoid-induced osteoporosis in long-term glucocorticoid administration patients

Region

Japan


Condition

Condition

glucocorticoid-induced osteoporosis

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to assess the efficacy of romosozumab in glucocorticoid-induced osteoporosis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The change of bone mineral density at 12 months after initiation of glucocorticoid therapy

Key secondary outcomes

The change of bone mineral density at 36 months after initiation of glucocorticoid therapy, the change of bone metabolism markers and adverse events during the observation period


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

romosozumab group -switch from bisphosphonate-

Interventions/Control_2

romosozumab group -switch from denosumab-

Interventions/Control_3

bisphosphonate group

Interventions/Control_4

denosumab group

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. Patients with systemic autoimmune diseases who received bisphosphonate or denosumab for more than half a year and received glucocorticoid therapy with prednisolone at doses over 5 mg daily
2. Patients who agree with this study

Key exclusion criteria

1. Patients who have received romosozumab
2. Patients with contraindication for romosozumab or denosumab or bisphosphonate
3. Patients with severe renal dysfunction (eGFR < 30mL/min/1.73m2)
4. Patients who is currently pregnant, breastfeeding or willing to get pregnant
5. Patients who do not give consent to the study
6. Patients who are judged to be inappropriate by the physician

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Mai
Middle name
Last name Kawazoe

Organization

Toho University School of Medicine

Division name

Division of Rheumatology, Department of Internal Medicine

Zip code

143-8541

Address

6-11-1 Omori-nishi, Ota-ku, Tokyo, Japan

TEL

03-3762-4151(6595)

Email

mai.kawazoe@med.toho-u.ac.jp


Public contact

Name of contact person

1st name Mai
Middle name
Last name Kawazoe

Organization

Toho University School of Medicine

Division name

Division of Rheumatology, Department of Internal Medicine

Zip code

143-8541

Address

6-11-1 Omori-nishi, Ota-ku, Tokyo, Japan

TEL

03-3762-4151(6595)

Homepage URL


Email

mai.kawazoe@med.toho-u.ac.jp


Sponsor or person

Institute

Toho University School of Medicine
Division of Rheumatology, Department of Internal Medicine

Institute

Department

Personal name



Funding Source

Organization

Toho University School of Medicine
Division of Rheumatology, Department of Internal Medicine

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

Division of Rheumatology, Department of Internal Medicine, Toho University School of Medicine

Address

6-11-1 Omori-nishi, Ota-ku, Tokyo, Japan

Tel

03-3762-4151(6595)

Email

mai.kawazoe@med.toho-u.ac.jp


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

2019 Year 07 Month 07 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

Open public recruiting

Date of protocol fixation

2019 Year 03 Month 26 Day

Date of IRB

2019 Year 06 Month 27 Day

Anticipated trial start date

2019 Year 07 Month 01 Day

Last follow-up date

2022 Year 06 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

2019 Year 07 Month 03 Day

Last modified on

2019 Year 07 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042467


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name