UMIN-CTR Clinical Trial

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
Institute	Kansai medical university, Kori Hospital
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042331