Evaluation of the effect of the combination of Teriparatide and Calcium supplement in comparison with Calcium supplement alone on intertrochanteric fracture healing
The aim of this study was to assess the efficacy of teriparatide in the repair of intertrochanteric fractures.
Design
Clinical trial with control group, doubled blind, randomized, phase 3 on 80 patients. Random numbers produced by an internet site https://www.random.org/ is used for randomization.
Settings and conduct
Study place: Orthopedic ward of Emam Hossein Hospital in Tehran.
Type of blinding: Double blind.
How to blind:
Participant; they assume that all participants have received the intervention and are unaware of the other group.
Outcome Assessor; A group of 2 orthopedic surgeons will evaluate radiography, fracture classification, reduction, fixation quality, and ionic process during the study without knowing the group of individuals, and will examine them separately, blinded, and separately using digital radiography. The opinion is examined by a third surgeon.
Data Analyzer: Without knowing the details of the control and experimental groups, analyzed the data in 2 separate groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People over 50 with Intertrochanteric fractures; use Teriparatide for a period of 3 months after surgery; Vitamin D with normal serum levels.
Non-inclusion criteria: unacceptable fracture reduction; multiple fractures; underlying conditions; self-medication that affects bone ;pathological fractures; absence of medical records
Intervention groups
Control group: patients undergoing gamma nail surgery and calcium supplementation alone.
Intervention group: patients who undergo surgery with the Gamma nail technique and in addition to calcium supplementation, also receive teriparatide.
Main outcome variables
Duration (weeks) of repair of intertrochantric fracture from the time of surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201121049452N1
Registration date:2021-01-24, 1399/11/05
Registration timing:retrospective
Last update:2021-01-24, 1399/11/05
Update count:0
Registration date
2021-01-24, 1399/11/05
Registrant information
Name
Behnam Navari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8602 5210
Email address
behnamtarinn@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of the combination of Teriparatide and Calcium supplement in comparison with Calcium supplement alone on intertrochanteric fracture healing
Public title
Effect of Teriparatide on Intertrochanteric Fractures Healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People over 50 years old with intertrochanteric fractures
use Triaparatide for a period of 3 months after surgery
Vitamin D with normal serum levels
Exclusion criteria:
Teriparatide is prescribed before surgery
Teriparatide is prescribed for less than 3 months
Unacceptable fracture reduction
Multiple fractures
Underlying conditions, or self-medication that affects bone repai
Contralateral pelvic fractures
Pathological fractures
Any anti-osteoporosis medication (except calcium and vitamin d tablets)
Deficiencies in medical records
Age
From 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method in this study was done by block randomization method in Excel software. So that after entering 80 samples (total number of people), the volume of group A was forty and the volume of group B was 40. Then, using the Random function tool in Excel software, the random number and random group of each sample were determined. The data evaluator is unaware of the random group of each sample.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant: Participants assume that all participants have received the intervention and are unaware of the other group.
Outcome Assessor: the radiographic evaluation, fracture classification, reduction, fixation quality and union process during the study will be reviewed by 2 blinded observer surgeon using digital radiographs on a computer Without knowing each person's group.In case of disagreement, the results will be reviewed blinded by a third surgeon.
Data Analyzer: Without knowing the details of the control and experimental group, analyzed the data in 2 separate groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
No 98 and 4; Mohandes alley; Adibi street; Shariati street
City
Tehran
Province
Tehran
Postal code
1613636681
Approval date
2020-06-07, 1399/03/18
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.200
Health conditions studied
1
Description of health condition studied
Intertrochanteric Fractures
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fracture healing time
Timepoint
Imaging at 2 and 4 weeks after surgery, then every 4 weeks until the fracture heals after taking teriparatide
Method of measurement
Radiological evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients undergoing gamma nail surgery also receive Teriparatide(Cinnopar-Cinnagen company) 20 micrograms subcutaneously per day from the day of discharge for 3 months in addition to calcium supplementation (600mg daily for 3 months).
Category
Treatment - Drugs
2
Description
Control group: Patients who undergo surgery with the Gamma nail technique and receive only calcium supplementation(600mg daily for 3 months).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hossein Hospital
Full name of responsible person
Mostafa Hassannejad
Street address
Emam Hossein Hospital, Madani street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
Info@ehmc.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
No 98 and 4; Mohandes alley; Adibi street; Shariati street
City
Tehran
Province
Tehran
Postal code
1613636681
Phone
+98 21 8602 5210
Email
Behnamtarinn@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Omidian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No 98 and 4; Mohandes alley; Adibi street; Shariati street
City
Tehran
Province
Tehran
Postal code
1613636681
Phone
+98 21 8602 5210
Email
Behnamtarinn@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Omidian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No 98 and 4; Mohandes alley; Adibi street; Shariati street
City
Tehran
Province
Tehran
Postal code
1613636681
Phone
+98 21 8602 5210
Email
Behnamtarinn@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Omidian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No 98 and 4; Mohandes alley; Adibi street; Shariati street
City
Tehran
Province
Tehran
Postal code
1613636681
Phone
+98 21 8602 5210
Email
Behnamtarinn@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
I would like to share the data file after deleting the confidential information. The total results of radiological evaluation of patients in 2 study groups will be presented.
When the data will become available and for how long
Start access 1 year after printing results
To whom data/document is available
physicians
Under which criteria data/document could be used
It is unknown at this time
From where data/document is obtainable
Send email to behnamtarinn@gmail.com
What processes are involved for a request to access data/document