UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018413
Receipt number R000021276
Scientific Title Efficacy of osteoporosis treatment in the clinical outcome after arthroscopic rotator cuff repair
Date of disclosure of the study information 2015/08/01
Last modified on 2015/07/24 15:42:01

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Basic information

Public title

Efficacy of osteoporosis treatment in the clinical outcome after arthroscopic rotator cuff repair

Acronym

Efficacy of osteoporosis treatment in the clinical outcome after arthroscopic rotator cuff repair

Scientific Title

Efficacy of osteoporosis treatment in the clinical outcome after arthroscopic rotator cuff repair

Scientific Title:Acronym

Efficacy of osteoporosis treatment in the clinical outcome after arthroscopic rotator cuff repair

Region

Japan


Condition

Condition

osteoporosis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Our objective of this study is to evaluate osteoporosis and fracture risk of patients undergoing ARCR surgery and to investigate an efficacy in the clinical outcome with PTH and anti-RANKL treatment.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

shoulder function
bone mineral density by DEXA
bone formation and resorption marker

Key secondary outcomes

change of bone mineral density of humeral head


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Teriparatide

Interventions/Control_2

Denosumab

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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with osteoporosis undergoing arthroscopic rotator cuff repair

provided a consent to participate in this study

Key exclusion criteria

patients undergoing treatment for osteoporosis

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Noriaki Okumura

Organization

Shiga University of Medical Science

Division name

Orthopaedic Surgery

Zip code


Address

Seta, Tsukinowa-cho, Otsu, Shiga

TEL

077-548-2252

Email

noriaki@belle.shiga-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Noriaki Okumura

Organization

Shiga University of Medical Science

Division name

Orthopaedic Surgery

Zip code


Address

Seta, Tsukinowa-cho, Otsu, Shiga

TEL

077-548-2252

Homepage URL


Email

noriaki@belle.shiga-med.ac.jp


Sponsor or person

Institute

Shiga University of Medical Science

Institute

Department

Personal name



Funding Source

Organization

Shiga University of Medical Science

Organization

Division

Category of Funding Organization

Self funding

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



Other administrative information

Date of disclosure of the study information

2015 Year 08 Month 01 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

Preinitiation

Date of protocol fixation

2015 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 01 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 07 Month 24 Day

Last modified on

2015 Year 07 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021276


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name