UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pharmacokinetics and safety of teriparatide in dialysis patients with osteoporosis
Title of the study (Brief title)	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	Yoshitaka Isaka
Organization	Osaka University Graduate School of Medicine
Division name	Geriatric Medicine and Nephrology
Address	2-2, Yamadaoka, Suita city
TEL	06-6879-3857
Email	isaka@kid.med.osaka-u.ac.jp

Public contact
Name of contact person	Takayuki Hamano
Organization	Osaka University Graduate School of Medicine
Division name	Comprehensive Kidney Disease Research
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 08 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000021655