UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018714 |
|---|---|
| Receipt number | 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 10:36:25 |
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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
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
hamatea@kid.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021655
