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IRCT138810121414N5 IRCT 2010-09-22 Cinagen biotechnology Comparing the effects of recombinant form of human PTH and the Brand type (Forteo) in improving Bone Mineral Density in patients having osteoporosis rhPTH vs FORTEO Comparing the effects of recombinant form of human PTH and the Brand type (Forteo) in improving Bone Mineral Density in patients having osteoporosis 2011-02-01 anticipated 92 Complete https://irct.ir/trial/667 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Osteoporosis. Intervention 1: Intervention group: Patients will receive daily dose of 20µg Cinagen rhPTH subcutaneously for 6 month. PTH will be prescribed in the morning via subcutaneous injection pen. Cartridges will be changed every 2 weeks. Intervention 2: Control group: Patients will receive daily dose of 20µg FORTEO subcutaneously for 6 month. FORTEO will be prescribed in the morning via subcutaneous injection pen. Cartridges will be changed every 2 weeks.
public
scientific Dr. Ramin Heshmat
North Karegar St, Dr. Shariati Hospital
Tehran Iran (Islamic Republic of) 1411413137 +98 21882200378 rheshmat@tums.ac.ir Endocrine & Metabolism Research Istitute, Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion Criteria: Patients are menopause women aged 45-75 who have following conditions: A) T-score less than -3 in lumbar vertebras, neck of femur or total hip in bone mass densitometry by DEXA method without evidences of fracture with low trauma due to osteoporosis. B) T-score less than -2.5 in one of mentioned regions due to osteoporosis with low trauma in vertebras or limbs. C) Women aged 55 and over with T-score less than -2.5 in one of regions of lumbar vertebras, neck of femur or total hip in bone mass densitometry by DEXA method without evidence of fracture with low trauma due to osteoporosis. D) Women aged 55 and over with T-score less than -2 at one of mentioned regions with history of fracture due to osteoporosis and low trauma in vertebras or limbs. Exclusion criteria: A) Rejecting to take part in the study and anticipating lack of cooperation during treatment and follow up periods. B) History of taking bone resorption inhibitor medications such as; Bisphosphanates at least for four weeks. C) Having a disease or being under treatment that interacts with bone metabolism and disrupts treatment process like auto-immune diseases, long term taking of Corticosteroid, chemotherapy or radiotherapy, epilepsy under treatment. D) Hypercalcemia above 10 mg/dl or hypercalceuria with ratio of Uca/Ucr>0.35, history of receiving PTH or stransium, history of urinary stones, advanced stage of liver or kidney disorders, intestinal malabsorbtion, hyper& hypoparathyroidism, hyperthyroidism, history of cancer in 5 years before the first visit, hyperuricemia and gout, lactation. 45 years 75 years Female M81.0, M80 Osteoporosis with and without pathological fracture Treatment - Drugs Treatment - Drugs Intervention group: Patients will receive daily dose of 20µg Cinagen rhPTH subcutaneously for 6 month. PTH will be prescribed in the morning via subcutaneous injection pen. Cartridges will be changed every 2 weeks Control group: Patients will receive daily dose of 20µg FORTEO subcutaneously for 6 month. FORTEO will be prescribed in the morning via subcutaneous injection pen. Cartridges will be changed every 2 weeks Bone markers. Timepoint: 1st, 3rd and 6th month of the study. Method of measurement: DEXA. Bone mineral density (BMD). Timepoint: At the beginning and 6 month after the start of study. Method of measurement: DXA. Fragility fracture prevention. Timepoint: 6 mounths after the start of the study. Method of measurement: thoracolumbar & Hip radiography. Cinagen biotechnology Approved Endocrine & Metabolism Research Institute North Karegar St, Dr. Shariati Hospital Tehran Iran (Islamic Republic of)