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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035845
Receipt No. R000040832
Scientific Title Examination of serum sclerostin levels and bone metabolism after gymnastics to increase of bone mineral density in healthy womeon
Date of disclosure of the study information 2019/02/13
Last modified on 2019/02/12

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Basic information
Public title Examination of serum sclerostin levels and bone metabolism after gymnastics to increase of bone mineral density in healthy womeon
Acronym Examination of serum sclerostin levels and bone metabolism after gymnastics to increase of bone mineral density in healthy womeon
Scientific Title Examination of serum sclerostin levels and bone metabolism after gymnastics to increase of bone mineral density in healthy womeon
Scientific Title:Acronym Examination of serum sclerostin levels and bone metabolism after gymnastics to increase of bone mineral density in healthy womeon
Region
Japan

Condition
Condition Healthy women
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy and safety of gymnastics to increase bone mineral density in gymnastics-instructed group versus gymnastics-uninstructed group
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bone mineral density
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 Gymnastics-instructed people to increase bone mineral density
Interventions/Control_2 Gymnastics-uninstructed people to increase bone mineral density
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
110 years-old >=
Gender Female
Key inclusion criteria Women who are more than 20 years old without osteoporosis
Key exclusion criteria 1 Osteoporosis patients under treatment
2 Patients who have had any fracture withina year prior to this study
3 Patients who have had heart disease which should be treated when doctors-in-charge judge them as unappropriate patients for this study
Target sample size 300

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yukio Nakamura
Organization Shinshu University School of Medicine
Division name Dept. of Orthopaedic Surgery
Zip code
Address Asahi 3-1-1, Matsumoto 3908621, Japan
TEL 0263372659
Email yxn14@aol.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yukio Nakamura
Organization Shinshu University School of Medicine
Division name Dept. of Orthopaedic Surgery
Zip code
Address Asahi 3-1-1, Matsumoto 3908621, Japan
TEL 0263372659
Homepage URL
Email yxn14@aol.jp

Sponsor
Institute Shinshu University School of Medicine
Dept. of Orthopaedic Surgery
Institute
Department

Funding Source
Organization Shinshu University School of Medicine
Dept. of Orthopaedic Surgery
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
2019 Year 02 Month 13 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 Open public recruiting
Date of protocol fixation
2019 Year 02 Month 05 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 12 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
2019 Year 02 Month 12 Day
Last modified on
2019 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040832

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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