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IRCT20210712051854N1 IRCT 2022-03-14 Daroo Salamat Pharmed Comparison of the effect of calcium carbonate and calcium hydroxyapatite supplementation on the prognosis of pertrochanteric fracture surgery Triple blind evaluation of the efficacy of oral calcium Hydroxy-apatite on postoperative pain and bone mineral density in patients after pertrochanteric fracture surgery 2022-03-21 anticipated 150 Complete https://irct.ir/trial/61677 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 150 packages of drugs containing tested drugs is prepared by the sponsoring company. Using simple randomization by computer software, one of the two types of calcium supplements is placed in each packet, and an ID is assigned to each packet. The coding table of IDs and its contents is prepared in a sealed envelope that will not be opened until the end of the study. In this way, the therapist and the patient and the data analyst will not be aware of the contents of the packages and the study will be conducted in a triple-blind manner, Blinding description: 150 drug packs containing vitamin D supplements, alendronate, and one of the two types of calcium carbonate or calcium hydroxyapatite supplements are prepared by the project sponsoring company with the same appearance and delivered to the researchers. The allocation of one of the two types of calcium supplements will be done by random numbers table and in such a way that each type of supplement is present in 75 packages out of a total of 150 packages. Researchers will assign medication packages to patients admitted to the study, respectively. Thereby, the patient and the physician, and the data analyzer will not be informed of the drugs allocated. For confidence, there will be two additional copies of the decoded table of numbers and contents of the packages in the hand of researchers and data analyzers, which will not be opened until the end of the research. 3 Pertrochanteric Fracture. Intervention 1: Control group: In addition to the post-protocol, daily calcium carbonate supplement for one month (totally, 30 tablets), Alendronate 70 mg once a week for three months (totally, 12 tablets), 3-Pearl Vit D 50000, one every two weeks for three months (totally, six tablets). All medicines and supplements are manufactured by Daru Salamat Pharmed Pharmaceutical Company. Intervention 2: Intervention group: In addition to the post-protocol, daily calcium hydroxyapatite supplement for one month (totally, 30 tablets), Alendronate 70 mg once a week for three months (totally, 12 tablets), 3-Pearl Vit D 50000, one every two weeks for three months (totally, six tablets). All medicines and supplements are manufactured by Daru Salamat Pharmed Pharmaceutical Company. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after anonymizing identifications When: After printing the results as an article To whom: Researchers working in academic institutions Conditions: For further research purposes and analysis Where to obtain: In order to receive the data, it is necessary to refer to the scientific accountant or the corresponding author of the article How to obtain: An official letter or e-mail Comments:
public Dr. Negar Mosavi Hasab
Unit 4, No. 27, Sharifi Brothers Alley, Above of Vanak Square, Valiasr St.
Tehran Iran (Islamic Republic of) 1969813635 +98 21 8819 2741 Negar.moosavi@daroosf.com Daroo Salamat Pharmed scientific Dr. Mohammad Hossein Nabian
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 mh-nabian@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) All patients over 65 years referred to Trauma Emergency of Shariati Hospital with pertrochanteric fracture who are candidates for surgery 65 years no limit Both Patients who are not candidates for surgery due to medical problems with an ASA score of 3 or higher Patients receiving osteoporosis treatments including bisphosphonates, calcium and vitamin D supplements, or hormone therapy prior to surgery S72.1 Pertrochanteric fracture Treatment - Drugs Treatment - Drugs Control group: In addition to the post-protocol, daily calcium carbonate supplement for one month (totally, 30 tablets), Alendronate 70 mg once a week for three months (totally, 12 tablets), 3-Pearl Vit D 50000, one every two weeks for three months (totally, six tablets). All medicines and supplements are manufactured by Daru Salamat Pharmed Pharmaceutical Company. Intervention group: In addition to the post-protocol, daily calcium hydroxyapatite supplement for one month (totally, 30 tablets), Alendronate 70 mg once a week for three months (totally, 12 tablets), 3-Pearl Vit D 50000, one every two weeks for three months (totally, six tablets). All medicines and supplements are manufactured by Daru Salamat Pharmed Pharmaceutical Company. Pain Rate Score. Timepoint: Immediately after surgery, 3 months after surgery, 6 months after surgery. Method of measurement: Visual Analog Scale Questionnaire. Bone Mineral Density. Timepoint: Immediately after surgery, 6 months after surgery. Method of measurement: Bone-marrow densitometry. Fracture Union. Timepoint: Every month. Method of measurement: Radiography. Possible side effects of the drug. Timepoint: 3 months after surgery, 6 months after surgery. Method of measurement: Patient's Record and History. Quadriceps Muscle Strength. Timepoint: After surgery, Third months follow-up, Sixth month follow-up. Method of measurement: Motor Function Measure. Weight Bearing Time. Timepoint: 3 months after surgery, 6 months after surgery. Method of measurement: Patient's Record and History. Daroo Salamat Pharmed Approved 2022-02-27 Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences Building no.1, Northern gate of the university, Poursina St. Qods St. Enqelab St. Tehran Tehran Iran (Islamic Republic of)