UMIN-CTR Clinical Trial

Basic information
Public title	Examination of bone volume and bone conditions by exercise for osteoporosis
Acronym	Are gymnastics effective to improve bone volume in osteoporosis?
Scientific Title	Examination of bone mineral density, serum sclerostin values, and bone metabolism after bone mineral density up gymnastics in osteoporosis patients
Scientific Title:Acronym	Examination of bone-related factors after exercise in osteoporosis patients
Region	Japan

Condition
Condition	Osteoporosis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We examine whether or not drop heel or Navel retraction gymnastics are effective for the following: 1. The increase of bone mineral density at proximal femoral sites and lumbar sites 2. The decrease of bone quality marker, AGEs, such as pentcidine. 3. The decrease of serum sclerostin levels. 4. The decrease of fracture frequencies of proximal femoral and compression vertebral sites
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Bone mineral density after the start of this study
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Patients who will have bone mineral density up gymnastics
Interventions/Control_2	Patients who will not have bone mineral density up gymnastics
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	120 years-old >=
Gender	Female
Key inclusion criteria	1. Osteoporosis patients who are more than 20 years old 2. Patients who have had consent for this study
Key exclusion criteria	1. Patients who have severe renal failure 2. Patients who have had fractures within a year 3. Patients whom we have evaluated as inapropriate
Target sample size	100

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

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

Sponsor
Institute	Shinshu University School of Medicine
Institute
Department

Funding Source
Organization	Shinshu University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shinshu University School of Medicine
Address	Asahi 3-1-1, Matsumoto 3908621, japan
Tel	0263372659
Email	yxn14@aol.jp

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 04 Month 09 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	Open public recruiting
Date of protocol fixation	2019 Year 04 Month 04 Day
Date of IRB	2019 Year 04 Month 04 Day
Anticipated trial start date	2019 Year 04 Month 04 Day
Last follow-up date	2024 Year 04 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 04 Month 08 Day
Last modified on	2019 Year 04 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041530