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IRCT20201121049452N1 IRCT 2021-01-24 Shahid Beheshti University of Medical Sciences Effect of Teriparatide on Intertrochanteric Fractures Healing Evaluation of the effect of the combination of Teriparatide and Calcium supplement in comparison with Calcium supplement alone on intertrochanteric fracture healing 2019-01-21 anticipated 80 Complete https://irct.ir/trial/52454 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Intertrochanteric Fractures. Intervention 1: 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). Intervention 2: Control group: Patients who undergo surgery with the Gamma nail technique and receive only calcium supplementation(600mg daily for 3 months). Yes - There is a plan to make this available What will be shared: 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: Start access 1 year after printing results To whom: physicians Conditions: It is unknown at this time Where to obtain: Send email to behnamtarinn@gmail.com How to obtain: unknown Comments:
public Mohammad Mehdi Omidian
No 98 and 4; Mohandes alley; Adibi street; Shariati street
Tehran Iran (Islamic Republic of) 1613636681 +98 21 8602 5210 Behnamtarinn@gmail.com Shahid Beheshti University of Medical Sciences scientific Mohammad Mehdi Omidian
No 98 and 4; Mohandes alley; Adibi street; Shariati street
Tehran Iran (Islamic Republic of) 1613636681 +98 21 8602 5210 Behnamtarinn@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) People over 50 years old with intertrochanteric fractures use Triaparatide for a period of 3 months after surgery Vitamin D with normal serum levels 50 years no limit Both 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 Treatment - Drugs Treatment - Drugs 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). Control group: Patients who undergo surgery with the Gamma nail technique and receive only calcium supplementation(600mg daily for 3 months). 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. Shahid Beheshti University of Medical Sciences Approved 2020-06-07 Ethics Committee of Shahid Beheshti University of Medical Sciences No 98 and 4; Mohandes alley; Adibi street; Shariati street Tehran Tehran Iran (Islamic Republic of)