UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017582 |
|---|---|
| Receipt number | R000020293 |
| Scientific Title | The effect of teriparatide in the treatment of nontraumatic osteonecrosis of the femoral head |
| Date of disclosure of the study information | 2015/05/15 |
| Last modified on | 2015/05/15 12:14:49 |
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Basic information
Public title
The effect of teriparatide in the treatment of nontraumatic osteonecrosis of the femoral head
Acronym
The effect of teriparatide in the treatment of nontraumatic osteonecrosis of the femoral head
Scientific Title
The effect of teriparatide in the treatment of nontraumatic osteonecrosis of the femoral head
Scientific Title:Acronym
The effect of teriparatide in the treatment of nontraumatic osteonecrosis of the femoral head
Region
| Japan |
Condition
Condition
Nontraumatic osteonecrosis of the femoral head
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the anti-collapse efficacy of teriparatide in the treatment of nontraumatic osteonecrosis of the femoral head.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effects of anti-collapse efficacy of teriparatide compared with alendronate
Key secondary outcomes
Base
Study type
Observational
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
| 19 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Nontraumatic osteonecrosis of the femoral head patients who were diagnosed with steroid-induced osteoporosis and received teriparatide or alendronate
Key exclusion criteria
We excluded
1) Patients who had been followed for less than 6 months
2) The administration periods were not identified
3) Stage 3B or 4 in the Japansese Investigation Committee staging system
4) Type A or B in the Japansese Investigation Committee classification system
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Takahashi |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Orthopaedic surgery
Zip code
Address
Kita 15 Nishi 7, Kita-ku, Sapporo, Hokkaido
TEL
011-716-1161
rainbow-quest@pop02.odn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryuta Arai |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Orthopaedic surgery
Zip code
Address
Kita 15 Nishi 7, Kita-ku, Sapporo, Hokkaido
TEL
011-716-1161
Homepage URL
ryutaaraisti@yahoo.co.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery, Hokkaido University Graduate 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
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 | 05 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective comparative analysis of teriparatide and alendronate in the treatment of nontraumatic osteonecrosis of the femoral head was performed.
Management information
Registered date
| 2015 | Year | 05 | Month | 15 | Day |
Last modified on
| 2015 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020293
