UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055856 |
|---|---|
| Receipt number | R000063836 |
| Scientific Title | Role of Teriperatide in Osteoporotic Intertrochanteric Femoral Fracture: a randomized controlled experimental study |
| Date of disclosure of the study information | 2024/10/16 |
| Last modified on | 2024/10/16 19:36:30 |
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Basic information
Public title
Role of Teriperatide in Osteoporotic Intertrochanteric Femoral Fracture
Acronym
Role of Teriperatide in Osteoporotic Intertrochanteric Femoral Fracture
Scientific Title
Role of Teriperatide in Osteoporotic Intertrochanteric Femoral Fracture: a randomized controlled experimental study
Scientific Title:Acronym
Role of Teriperatide in Osteoporotic Intertrochanteric Femoral Fracture: a randomized controlled experimental study
Region
| Asia(except Japan) |
Condition
Condition
Osteoporotic patients who suffered Intertrochanteric Femoral Fracture
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the role of teriparatide therapy in surgically fixed osteoporotic intertrochanteric femur fractures with respect to fracture healing time and bone turnover markers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone Turnover Markers
Radiographic Union Score for Hip
Bone Mineral Density Hip
T score hip
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Daily 20mcg subcutaneous Teriparatide acetate for 6 months
Interventions/Control_2
Oral calcium & vitamin D3 supplementation for 6 months
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All Intertrochanteric fractures which are surgically fixed with cephalomedullary nail with T score < -2.5 on DEXA scan
Age > 50 years
Key exclusion criteria
Patient with age < 50 years.
Pathological fractures of any other cause than osteoporosis
Patients already on Teriperatide therapy, or any other anti-osteoporotic medications
Patients with incomplete medical record
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ankit |
| Middle name | |
| Last name | Chalana |
Organization
Government Medical College, Patiala, India
Division name
Department of Orthopedics, Patiala, India
Zip code
147001
Address
Government Medical College, Patiala, India
TEL
+917300324082
ankit24082@gmail.com
Public contact
Name of contact person
| 1st name | Ankit |
| Middle name | |
| Last name | Chalana |
Organization
Government Medical College Rajindra Hospital, Patiala, India
Division name
Department of Orthopedics, Patiala, India
Zip code
147001
Address
Government Medical College, Patiala, India
TEL
+917300324082
Homepage URL
ankit24082@gmail.com
Sponsor or person
Institute
Department of Orthopedics, Government Medical College, Patiala, India
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopedics, Government Medical College, Patiala, India
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
Government Medical College Rajindra Hospital, Patiala
Address
Institutional Ethical Committee, Government Medical College, Patiala, India
Tel
+917300324082
ankit24082@gmail.com
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
Department of Orthopedics (Government Medical College, Patiala, India)
Affiliated to
Baba Farid University to Health Sciences
Faridkot, India
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 16 | 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
50
Results
After 6 months of study, Bone Mineral Density (BMD), Bone Turnover Markers (BTMs), and fracture healing using the RUSH score were assessed. The study group showed a 2-3 times increase in BTMs compared to the control. Significant improvement in hip BMD and T-score was noted in the study group.
Results date posted
| 2024 | Year | 10 | 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
| 2023 | Year | 01 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The present study protocol was reviewed and approved by the ethical committee of Government Medical College; Patiala affiliated to Baba Farid University to Health Sciences (approval No. BFUHS/2K23p-TH/1409).
The study was conducted as a thesis for MS(Orthopaedics) degree, and has been submitted to Baba Farid University to Health Sciences, Faridkot.
Management information
Registered date
| 2024 | Year | 10 | Month | 16 | Day |
Last modified on
| 2024 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063836
