Osteopenia. Postmenopausal osteoporosis
Conditions
Interventions
Intervention 1: placebo, 150 mg,once daily,12 weeks. Intervention 2: Oligopin ,150 mg ,once daily, 12 week.
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
50 Years to 65 Years
Inclusion criteria
Inclusion criteria: Postmenopausal women; Aged between 50-65; Diagnosis of osteopenia based on Tscore ( -2.5 SD = Tscore = -1 SD) To have equal physical, pediatric and complementary therapies for at least three months before entrance to study
Exclusion criteria
Exclusion criteria: The subjects were excluded if they had body mass index = 40 kg/m2, the occurrence of any visible side effects of the intervention,fracture report during the follow-up period, refusal to continue the trial, history of bone disorders, history of any malignancy, diabetes, kidney failure, hepatic disease, skeletal disorders, systemic inflammatory diseases, rheumatologic disorders, degenerative joint diseases, hyperthyroidism, Cushing's syndrome, history of gastrointestinal disease or bleeding, motor disabilities, untreated psychiatric illnesses such as Alzheimer's disease, Parkinson's disease, psychosis, and current smoking and alcohol intake.As for the history of the use of drugs, women receiving osteoporosis drugs (e.g. estrogen receptor-selective agonists / antagonists, bisphosphonates, PTH, and alternative HRTs), anticonvulsants (i.e. phenobarbital, phenytoin, sodium valproate), nonsteroidal anti-inflammatory drugs (i.e. naproxen, aspirin, and ibuprofen), thiazides, diuretics, glucocorticoids were not permitted to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Carboxy terminal collagen type I. Timepoint: Before and third month after intervention. Method of measurement: ELISA.;Osteocalcin. Timepoint: Before and third month after intervention. Method of measurement: ELISA.;Osteocalcin/CTX1 ratio. Timepoint: Before and third month after interventio. Method of measurement: --. | — |
Secondary
| Measure | Time frame |
|---|---|
| MnSOD activity in plasma and peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent controls. Timepoint: At first of study,third month. Method of measurement: spectrophotometer.;Catalse activity in plasma and peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent controls. Timepoint: Before intervention,third month after intervention. Method of measurement: spectrophotometer.;NrF2 gene expression in peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent controls. Timepoint: Before intervention,third month after intervention. Method of measurement: Real-Time PCR.;MnSOD expression in peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent controls. Timepoint: Before intervention,third month after intervention. Method of measurement: real-time PCR.;Catalase expression in peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent controls. Timepoint: Before intervention,third month after intervention. Method of measurement: real-time PCR.;MDA plasma levels in postmenopausal osteopenic women and placebo-concurrent controls. Timepoint: Before intervention,third month after intervention. Method of measurement: spectrophotometer.;Plasma levels of total antioxidant capacity in postmenopausal osteopenic women and placebo-concurrent controls. Timepoint: Before intervention,third month after intervention. Method of measurement: spectrophotometer.;Evaluating plasma levels of protein carbonylation in postmenopausal osteopenic women and placebo-concurrent controlsP. Timepoint: Before intervention,third month after intervention. Method of measurement: spectrophotometer.;Evaluating plasma levels of total thiol contents in postmenopausal osteopenic women and placebo-concurrent controls. Timepoint: Before intervention,third month after intervention. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSolaleh Emamgholipour
Tehran University of Medical Sciences
Outcome results
None listed