Comparing the effects of recombinant form of human PTH and the Brand type (Forteo) in improving Bone Mineral Density in patients having osteoporosis

Phase 3

• Conditions: Osteoporosis.; Osteoporosis with and without pathological fracture; M81.0, M80

• Registration Number: IRCT138810121414N5
• Lead Sponsor: Cinagen biotechnology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 92

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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Fragility fracture prevention. Timepoint: 6 mounths after the start of the study. Method of measurement: thoracolumbar & Hip radiography.