UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055818 |
|---|---|
| Receipt number | R000063801 |
| Scientific Title | The effectiveness and safety of testosterone replacement therapy in the musculoskeletal system of males with hypogonadism: A systematic review and meta-analysis |
| Date of disclosure of the study information | 2024/10/12 |
| Last modified on | 2025/01/16 09:23:55 |
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Basic information
Public title
The effectiveness and safety of testosterone replacement therapy in the musculoskeletal system of males with hypogonadism: A systematic review and meta-analysis
Acronym
Testosterone replacement therapy in hypogonadism
Scientific Title
The effectiveness and safety of testosterone replacement therapy in the musculoskeletal system of males with hypogonadism: A systematic review and meta-analysis
Scientific Title:Acronym
Testosterone replacement therapy in hypogonadism
Region
| Japan | North America |
Condition
Condition
hypogonadism
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the impact of Testosterone replacement therapy on hypogonadism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome was the change in body composition.
Key secondary outcomes
The secondary outcomes included skeletal and muscle function (risk of fracture, handgrip strength, and forearm bone mineral density [BMD]) and metabolism (high-density lipoprotein cholesterol [HDL], low-density lipoprotein cholesterol [LDL], triglycerides [TG], and homeostatic model assessment for insulin resistance [HOMA-R] for patients with type 2 diabetes mellitus [T2DM]).
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
No restrictions were placed on article types or publication language. To be included, a study had to meet the following criteria: 1) It was a placebo-controlled randomized trial; 2) It involved patients with hypogonadism; and 3) The treatment duration was more than 24 weeks or six months.
Key exclusion criteria
Exclusion criteria were: 1) treatment with supplements; 2) not being a randomized controlled trial (RCT); and 3) insufficient data.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Ryusuke |
| Middle name | |
| Last name | Ochiai |
Organization
Teikyo University Hospital
Division name
Department of Oncology,
Zip code
173-8606
Address
2-11-1 Kaga, Itahashi, Tokyo
TEL
03-3964-1211
ryo7132003@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryusuke |
| Middle name | |
| Last name | Ochiai |
Organization
Teikyo University Hospital
Division name
Department of Oncology
Zip code
173-8606
Address
2-11-1 Kaga, Itahashi, Tokyo
TEL
03-3964-1211
Homepage URL
ryo7132003@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University Hospital
Institute
Department
Personal name
Funding Source
Organization
Teikyo University Hospital
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
Teikyo University Hospital
Address
2-11-1 Kaga, Itahashi, Tokyo
Tel
03-3964-1211
ryo7132003@med.teikyo-u.ac.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
| 2024 | Year | 10 | Month | 12 | 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
5198
Results
TRT is a safe and effective treatment for men with hypogonadism. Long-term use of TRT can improve BMI and LBM, though it does not appear to enhance handgrip strength or BMD. A combined approach of TRT and exercise may be an important strategy for optimizing outcomes
Results date posted
| 2025 | Year | 01 | Month | 16 | Day |
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
| 2024 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not available
Management information
Registered date
| 2024 | Year | 10 | Month | 12 | Day |
Last modified on
| 2025 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063801
