Osteopenia. Age-related osteoporosis without current pathological fracture
Conditions
Interventions
Intervention 1: Intervention group: Osteopenic postmenopausal women, will be ordered Padzahr tablet: 6 tablets daily, divided in 3 doses. Intervention 2: Control group: Osteopenic postmenopausal wome
Sponsors
Niak company
Eligibility
Sex/Gender
Female
Age
45 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Turnover of bone formation based on Laboratory tests. Timepoint: Baseline and after 3 months. Method of measurement: ELISA laboratory tests. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactShabnam Rafiee
Tehran University of Medical Sciences
Outcome results
None listed