Osteoporosis. Osteoporosis with and without pathological fracture
Conditions
Interventions
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
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
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
Sponsors
Cinagen biotechnology
Eligibility
Sex/Gender
Female
Age
45 Years to 75 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Fragility fracture prevention. Timepoint: 6 mounths after the start of the study. Method of measurement: thoracolumbar & Hip radiography. | — |
Countries
Iran (Islamic Republic of)
Outcome results
None listed