UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037146
Receipt number R000042331
Scientific Title A randomized comparative study between the parallel group to evaluate the efficacy of drinking some water immediately before the administration of Teriparatide acetate for preventing the incidence of nausea
Date of disclosure of the study information 2019/08/01
Last modified on 2019/06/24 12:33:31

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Basic information

Public title

A comparative study of efficacy of drinking water on declining the incidence of nausea after administration of Teriparatide acetate

Acronym

A comparative study of efficacy of drinking water on declining the incidence of nausea after administration of Teriparatide acetate

Scientific Title

A randomized comparative study between the parallel group to evaluate the efficacy of drinking some water immediately before the administration of Teriparatide acetate for preventing the incidence of nausea

Scientific Title:Acronym

A comparative study of efficacy of drinking water on declining the incidence of nausea after administration of Teriparatide acetate

Region

Japan


Condition

Condition

Osteoporosis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objectives of this study are revealing the efficacy of drinking water immediately before the administration of Teriparatide acetate on declining the incidence of nausea, a common adverse event after administration.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary outcomes are the incidence of nausea after the administration of Teriparatide acetate.

Key secondary outcomes

The secondary outcomes are the change of blood pressures immediately after administration of Teriparatide acetate and persistence rate of the administration.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1


In this study, we randomly divide the patients who are diagnosed primary osteoporosis into two groups to treat with teriparatide acetate. In one group (25 of 50 cases), patients let be drank a cup of water in treatment room under observation of medical stuffs.
And other treatments are same among two groups. All of 50 cases are measured blood pressure before the administration of teriparatide acetate, and half an hour after the administration. Furthermore, all cases are asked the incidence of nausea.
The administration of teriparatide acetate is performed weekly, totally 104 times. In this period, the general examinations are performed every time, and patients are asked after administration the incidence of nausea and other adverse events. The measurement of blood pressure is performed at the first time of the administration and 2nd, 3rd, 4th, 5th, 9th, 25th, 53rd, and 104th.

Interventions/Control_2

In this study, we randomly divide the patients who are diagnosed primary osteoporosis into two groups to treat with teriparatide acetate. In another group (25 of 50 cases), patients let be drank a cup of water in treatment room under observation of medical stuffs.
And other treatments are same among two groups. All of 50 cases are measured blood pressure before the administration of teriparatide acetate, and half an hour after the administration. Furthermore, all cases are asked the incidence of nausea.
The administration of teriparatide acetate is performed weekly, totally 104 times. In this period, the general examinations are performed every time, and patients are asked after administration the incidence of nausea and other adverse events. The measurement of blood pressure is performed at the first time of the administration and 2nd, 3rd, 4th, 5th, 9th, 25th, 53rd, and 104th.

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

65 years-old <=

Age-upper limit


 Not applicable

Gender

Female

Key inclusion criteria

1)Female
2)Over 65 years old
3)Out patients
4)Primary osteoporosis with high risks of fragile fracture
5)Patients with sufficient informed consent to participate this study

Key exclusion criteria

1)Patients with contraindication for the administration of teriparatide acetate
2)Patients who cannot drink a water orally
3)Patients who already had finished 104 times of the administration of teriparatide acetate, or were administrated several times
4)Patients who refused to participate this study by sufficient information
5)Other patients who are judged inappropriate to participate this study by director of this study

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Yusuke
Middle name
Last name Ueda

Organization

Kansai medical university, Kori Hospital

Division name

Department of Orthopedic surgery

Zip code

572-8551

Address

8-45 Hondori-cho, Neyagawa-shi, Osaka, Japan

TEL

072-832-5321

Email

uedayu@kouri.kmu.ac.jp


Public contact

Name of contact person

1st name Yusuke
Middle name
Last name Ueda

Organization

Kansai medical university, Kori Hospital

Division name

Department of Orthopedic surgery

Zip code

572-8551

Address

8-45 Hondori-cho, Neyagawa-shi, Osaka, Japan

TEL

072-832-5321

Homepage URL


Email

uedayu@kouri.kmu.ac.jp


Sponsor or person

Institute

Kansai medical university, Kori Hospital

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


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kansai medical university, Kori hospital, ethical review board

Address

8-45 Hondori-cho, Neyagawa-shi, Osaka, Japan

Tel

072-832-5321

Email

kansaik@kouri.kmu.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 08 Month 01 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

Preinitiation

Date of protocol fixation

2019 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2019 Year 08 Month 01 Day

Last follow-up date

2022 Year 07 Month 31 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 06 Month 24 Day

Last modified on

2019 Year 06 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042331


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name