UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018260 |
|---|---|
| Receipt number | R000021129 |
| Scientific Title | Effects of denosumab on bones in patients with cementless total hip arthroplasty |
| Date of disclosure of the study information | 2015/07/10 |
| Last modified on | 2015/07/09 20:09:02 |
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Basic information
Public title
Effects of denosumab on bones in patients with cementless total hip arthroplasty
Acronym
Effects of denosumab on bones in patients with cementless total hip arthroplasty
Scientific Title
Effects of denosumab on bones in patients with cementless total hip arthroplasty
Scientific Title:Acronym
Effects of denosumab on bones in patients with cementless total hip arthroplasty
Region
| Japan |
Condition
Condition
Total hip arthroplasty
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relation between effects of denosumab on bone metabolism and nutrition/physical activity in patients with cementless total hip arthroplasty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone mineral density
Bone metabolism markers
Nutrient intake
Physical activity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Denosumab injection
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Unilateral cementless total hip arthroplasty
More than 6 months after the operation
Key exclusion criteria
Hypocalcemia
Severe renal dysfunction
Previous treatment using denosumab, bisphosphonates or teriparatide
Previous treatment using other osteoporosis drugs during the past 6 months
Diseases or treatments associated with bone metabolism
Plan for invasive dental treatment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromi Oda |
Organization
Saitama Medical University
Division name
Department of Orthopaedic Surgery
Zip code
Address
38 Morohongo, Moroyama, Saitama, Japan
TEL
049-276-1238
hoda@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisuke Watarai |
Organization
Saitama Medical University
Division name
Department of Orthopaedic Surgery
Zip code
Address
38 Morohongo, Moroyama, Saitama, Japan
TEL
049-276-1238
Homepage URL
kwatarai@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
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
Address
Tel
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 | 07 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 10 | 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 | 09 | Day |
Last modified on
| 2015 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021129
