UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036442 |
|---|---|
| Receipt number | R000041530 |
| Scientific Title | Examination of bone mineral density, serum sclerostin values, and bone metabolism after bone mineral density up gymnastics in osteoporosis patients |
| Date of disclosure of the study information | 2019/04/09 |
| Last modified on | 2019/04/08 15:17:40 |
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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
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
yxn14@aol.jp
Public contact
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
yxn14@aol.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041530
