UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037394
Receipt number R000042631
Scientific Title Evaluation of efficacy and safety of romosozumab administration group and ibandronate sodium hydrate administration group for osteoporosis patients after denosumab treatment
Date of disclosure of the study information 2019/07/17
Last modified on 2019/07/17 10:09:39

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Evaluation of efficacy and safety of romosozumab administration group and ibandronate sodium hydrate administration group for osteoporosis patients after denosumab treatment

Acronym

Evaluation of efficacy and safety of romosozumab administration group and ibandronate sodium hydrate administration group for osteoporosis patients after denosumab treatment

Scientific Title

Evaluation of efficacy and safety of romosozumab administration group and ibandronate sodium hydrate administration group for osteoporosis patients after denosumab treatment

Scientific Title:Acronym

Evaluation of efficacy and safety of romosozumab administration group and ibandronate sodium hydrate administration group for osteoporosis patients after denosumab treatment

Region

Japan


Condition

Condition

osteoporosis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to examine the efficacy and safety of the two treatments of romosozumab group and ibandronate sodium hydrate group in cases where bone density has increased after administration of denosumab for 2 or more years to osteoporosis patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Bone density at 12 months of treatment
Younger average 80% achieved

Key secondary outcomes

Occurrence of hypocalcemia
Occurrence of other adverse events


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

romosozumab group

Interventions/Control_2

ibandronate sodium hydrate group

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.All osteoporosis patients over 20 years old
2. Patients who have already received Denosumab (60 mg once every 6 months) for 2 years or more before the start of the study, and have a bone density value of -2.0 SD or more
3.Patients who received written informed consent based on their own free will after receiving sufficient explanation for participation in this study

Key exclusion criteria

1. If you had previously been treated with romosozumab, ibandronate sodium hydrate
2. If you are allergic to romosozumab, ibandronate sodium hydrate
3. Those who have hypocalcemia
4. For pregnant women or women who are nursing
5.Patients with disorders that delay esophageal passage such as esophageal stricture or achalasia
6.Patients who can not keep standing or sitting for more than 60 minutes when taking
7. Those with severe renal dysfunction (eGFR 30 ml / min / less than 1.73 m2) or those receiving dialysis
8.Patients with upper digestive tract disorder such as dysphagia, esophagitis, gastritis, duodenitis, ulcer etc.
9. Other patients who the research director judged inappropriate as a subject

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Yukio
Middle name
Last name Nakamura

Organization

Shinshu University School of Medicine

Division name

Dept. of Orthopaedic Surgery

Zip code

390-8621

Address

Asahi 3-1-1, Matsumoto 3908621, Japan

TEL

0263372659

Email

yxn14@aol.jp


Public contact

Name of contact person

1st name Yukio
Middle name
Last name Nakamura

Organization

Shinshu University School of Medicine

Division name

Dept. of Orthopaedic Surgery

Zip code

390-8621

Address

Asahi 3-1-1, Matsumoto 3908621, Japan

TEL

0263372659

Homepage URL


Email

yxn14@aol.jp


Sponsor or person

Institute

Shinshu University School of Medicine
Dept. of Orthopaedic Surgery

Institute

Department

Personal name



Funding Source

Organization

Shinshu University School of Medicine
Dept. of Orthopaedic Surgery

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

hinshu University School of Medicine Dept. of Orthopaedic Surgery

Address

Asahi 3-1-1, Matsumoto 3908621, Japan

Tel

0263372659

Email

yxn14@aol.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 17 Day


Related information

URL releasing protocol


Publication of results

Partially published


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 07 Month 01 Day

Date of IRB

2019 Year 07 Month 11 Day

Anticipated trial start date

2019 Year 07 Month 16 Day

Last follow-up date

2024 Year 07 Month 02 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 17 Day

Last modified on

2019 Year 07 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042631


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name