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IRCT20210803052067N1 IRCT 2021-09-21 Artesh University of Medical Sciences Bone density changes before and after administration of danozoomab Evaluation of bone density changes before and after administration of at least one year of danozoomab in patients referred to Imam Reza Hospital 2020-07-20 anticipated 202 Complete https://irct.ir/trial/58219 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 3 Osteoporosis. Intervention group: After performing a bone density test and assuring osteoporosis, the person will receive a 60 mg dose of denosumab(Xgeva®, produced by Amgen ) subcutaneously at baseline and 6 months later. 6 months after the injection, the person will have a bone resuscitation test and the effectiveness of the denosumab will be checked.. Yes - There is a plan to make this available What will be shared: A portion of the data that represents the final outcome When: Access will be 6 months after the results are printed. To whom: All physicians and residents of the field of medical sciences Conditions: After obtaining permission from the deputy research group Where to obtain: The person responsible for scientific accountability study How to obtain: First approved by the Research Vice-President Comments:
public Dr. Mohsen Ghasemzadeh Soroush
Emam Reza hospital (501 Artesh), Shahid Etemadzade St, west Fatemi AV, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1411718541 +98 21 8802 8350 mohsensoroosh@gmail.com Artesh University of Medical Sciences scientific Dr. Mohsen Akhyani
Doctors Building 110,Beheshti street,shohada square,karaj.
Karaj Iran (Islamic Republic of) 3134896197 +98 26 3221 6867 Mohsen.akhiani7@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) Postmenopausal women (aged 45 to 75 years old) diagnosed with osteoporosis by densitometry via Dexa(dual energy Xray absorptiometry). 45 years 75 years Female Lack of consent for being in the trial Having hypersensitivity to denosumab or any component in the formulation Malabsorption syndrome History of thyroid surgery, parathyroid surgery or intestinal resection which has been caused malabsorption Patient M80 Osteoporosis with current pathological fracture Treatment - Drugs Intervention group: After performing a bone density test and assuring osteoporosis, the person will receive a 60 mg dose of denosumab(Xgeva®, produced by Amgen ) subcutaneously at baseline and 6 months later. 6 months after the injection, the person will have a bone resuscitation test and the effectiveness of the denosumab will be checked. Percentage change in Bone mineral density(BMD) at the lumbar spine (L1-L4), femoral neck, and total hip. Timepoint: Baseline and at 12th month of the study. Method of measurement: BMD by dual-energy x-ray absorptiometry Hologic 4500 or higher. (T score). Timepoint: At the beginning of the study and12 months later. Method of measurement: Bone densitometry. Artesh University of Medical Sciences Approved 2020-06-06 Ethics Committee of Tehran University of Medical Science First floor, NO 21,Dameshgh st, Felestin st.Keshavar Blv Tehran Tehran Iran (Islamic Republic of)