The effect of Padzahr tablet on Osteopenia
- Conditions
- Osteopenia.Age-related osteoporosis without current pathological fracture
- Registration Number
- IRCT20180710040406N1
- Lead Sponsor
- iak company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 44
Osteopenic postmenopausal women
Greater than 45 and under 65 years of age
Osteopenia, based on WHO definition: T Score between -2.5 and -1
No history of allergy and anaphylaxis
Use of Tobacco products, Alcohol and narcotic products
History of choronic diseases, including Cancer, Cardiovascular diseases, Diabetes mellitus, Renal failure, Liver diseases, Systemic inflammatory diseases, Degenerative joint diseases, Rheumatologic disorders, Thalassemia, Primary hyperparathyroidism, Hyperthyroidism, Cushing's syndrome, Hypercalciuria, Hypogonadism
Gastrointestinal diseases, including Crohn's disease, Ulcerative colitis, Celiac, Choronic diarrhea, under treatment gastric or duodenal ulcer, history of gastrointestinal bleeding
History of drug consumption, affecting bone metabolism like Osteoporosis drugs , Diuretics, Thiazides, Anti convulsive drugs, Glucocorticoides and NSAIDES
Motor disability and skeletal disorders except Osteopenia
Untreated psychologic or neurologic diseases like Psychosis, Alzheimer and Parkinson Diseases
History of bone diseases
No tendency for randomization
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Turnover of bone formation based on Laboratory tests. Timepoint: Baseline and after 3 months. Method of measurement: ELISA laboratory tests.
- Secondary Outcome Measures
Name Time Method Plasma Osteocalcin (OC). Timepoint: At the beginning of the study and 3 months after start of drug using. Method of measurement: Elisa Test.;Plasma Bone Alkaline Phosphatase (BAP). Timepoint: At the beginning of the study and 3 months after start of drug using. Method of measurement: Elisa Test.;Plasma Procollagen Type 1 N-Terminal Propeptide (P1NP). Timepoint: At the beginning of the study and 3 months after start of drug using. Method of measurement: Elisa Test.;Plasma C-terminal telopeptide (carboxy-terminal collagen crosslinks) (CTX). Timepoint: At the beginning of the study and 3 months after start of drug using. Method of measurement: Elisa Test.