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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009907
Receipt No. R000011486
Scientific Title Safety and efficacy of teriparatide in dialysis patients with osteoporosis
Date of disclosure of the study information 2013/01/30
Last modified on 2015/08/03

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Basic information
Public title Safety and efficacy of teriparatide in dialysis patients with osteoporosis
Acronym Teriparatide for dialysis patients with osteoporosis
Scientific Title Safety and efficacy of teriparatide in dialysis patients with osteoporosis
Scientific Title:Acronym Teriparatide for dialysis patients with osteoporosis
Region
Japan

Condition
Condition low-PTH osteoporosis in dialysis patients
Classification by specialty
Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the safety and efficacy of teriparatide treatment for low- PTH osteoporosis with dialysis patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change of bone mineral density
Key secondary outcomes Change of serum marker related to bone metabolism.
Incidence of bone fracture after teriparatide therapy.
Incidence of lumbago and abdominal pain.
Side-effect and tolerance rate

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Intact PTH lower than 60 pg/ml
2. Osteoporosis (T score <-2.5)
3. Low bone mass (T-score between -1.0 and -2.5 at the femoral neck or spine) with fragility fracture, with family history of proximal femur fracture, or with more than 15% of FRAX score (10-year probability of a major osteoporosis-related fracture).
Key exclusion criteria 1. Dialysis vintage less than 1 year
2. Patietns with Paget's disease or having high alkaline phosphatase.
3. Previous history of radiation therapy affecting bone.
4. Bone related malignancy, including bone metastasis
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenmei Takaichi
Organization Toranomon Hospital
Division name Nephrology Center
Zip code
Address 2-2-2, Toranomon, Minato-ku, Tokyo
TEL 03-3588-1111
Email takaichi@toranomon.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junichi Hoshino
Organization Toranomon Hospital
Division name Nephrology Center
Zip code
Address 2-2-2, Toranomon, Minato-ku, Tokyo
TEL +81-3-3588-1111
Homepage URL
Email hoshino@toranomon.gr.jp

Sponsor
Institute Nephrology Center, Toranomon Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

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 虎の門病院(東京都)、虎の門病院分院(神奈川県)

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 30 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2013 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 30 Day
Last follow-up date
2015 Year 01 Month 01 Day
Date of closure to data entry
2015 Year 01 Month 01 Day
Date trial data considered complete
2015 Year 02 Month 01 Day
Date analysis concluded
2015 Year 05 Month 31 Day

Other
Other related information prospective cohort study

Management information
Registered date
2013 Year 01 Month 30 Day
Last modified on
2015 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011486

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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