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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018714
Receipt No. R000021655
Scientific Title Pharmacokinetics and safety of teriparatide in dialysis patients with osteoporosis
Date of disclosure of the study information 2015/08/18
Last modified on 2016/08/23

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Basic information
Public title Pharmacokinetics and safety of teriparatide in dialysis patients with osteoporosis
Acronym TERIYAKI study (teriparatide therapy in osteoporosis patients with end stage kidney disease)
Scientific Title Pharmacokinetics and safety of teriparatide in dialysis patients with osteoporosis
Scientific Title:Acronym TERIYAKI study (teriparatide therapy in osteoporosis patients with end stage kidney disease)
Region
Japan

Condition
Condition osteoporosis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the pharmacokinetics and safty of single administration of teriparatide in dialysis patients with osteoprosis
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes the concentration of 1-34 PTH
Key secondary outcomes safety
serial trends of bone turnover markers

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 single administration of teriparatide 56.5 microgram
Interventions/Control_2 single administration of normal saline
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
100 years-old >=
Gender Female
Key inclusion criteria *Outpatients and inpatients with osteoporosis
*Patients with whole PTH less than 100 pg/mL
*Any etiologies of kidney disease
patients with hemoglobin greater than 10 g/dL
*Patients with informed consent
Key exclusion criteria *Patients with asthmatic diathesis and *Patients who develop a rash or symptom of irritation easily
*Patients out of the reference ranges of ionized calcium or corrected calcium
*Pregnant patients
*Patients with severe cardiac or hepatic disease
*Patients with dementia or psychiatric disease
*Transplant recipients
*Patients whose doses or kinds of antihypertensive drug were changed within the previous 2 weeks
*Patients with high risk of osteosarcoma
*Patients with primary or metastatic bone tumor
*Patients who had been treated with teriparatide over 72 weeks
*Patients regarded as inappropriate by researchers
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Isaka
Organization Osaka University Graduate School of Medicine
Division name Geriatric Medicine and Nephrology
Zip code
Address 2-2, Yamadaoka, Suita city
TEL 06-6879-3857
Email isaka@kid.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Hamano
Organization Osaka University Graduate School of Medicine
Division name Comprehensive Kidney Disease Research
Zip code
Address 2-2, Yamadaoka, Suita city
TEL 06-6879-3857
Homepage URL
Email hamatea@kid.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 大阪大学医学部附属病院(吹田市)、貴生病院(大阪府)

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 18 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 Enrolling by invitation
Date of protocol fixation
2015 Year 08 Month 13 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 18 Day
Last modified on
2016 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021655

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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