UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009907
Receipt number 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 08:59:46

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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 or person

Institute

Nephrology Center, Toranomon 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

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

Value
https://center6.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