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 |
* 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
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
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
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
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
