Postmenopausal osteoporosis. Osteoporosis without current pathological fracture
Conditions
Interventions
Intervention 1: Intervention group 1: One Nigella Sativa oil soft-gel capsule 1000 mg once a day prepared by Baryj Essence pharmaceutical company and one Curcumin placebo capsule containing 80 mg carb
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
50 Years to 65 Years
Inclusion criteria
Inclusion criteria: Postmenopausal women aged 50 to 65 years Ability to self-care Resident of Tabriz city Menstrual cessation for at least 12 consecutive months Low bone density (T-score <-2.5) in lumbar spine or hip (total and femoral neck) No fracture history The ability to communicate verbally for answering questions
Exclusion criteria
Exclusion criteria: T-score=-4 in lumbar spine or T-score=-3.5 in femoral neck bone Renal failure and diseases Bone disease other than osteoporosis The use of medications that affect bone metabolism, including intravenous bisphosphonate over the past 5 years, oral bisphosphonate use in the last 6 months, cumulative oral bisphosphonate use for more than 3 years, or more than 1 month between 6-12 months before the study, Use of parathyroid hormone analogues over the past 12 months or strontium, fluoride or cathepsin k inhibitor at any time, use of hormonal medications or corticosteroids during the study or within 3 months before (or more). Chronic liver disease Other systemic diseases, such as diabetes, gastrointestinal disorders, and endocrine disorders Mental illness, as reported by the woman The malignancy, as reported by the woman Taking anti-coagulants, and coagulation disorders Stomach ulcers and gallstones The levels of 25-hydroxyvitamin D less than 20ng/ ml Current Hypercalcemia or hypocalcemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone mineral density. Timepoint: At the baseline (before intervention) and just after completion of the intervention (6 months after beginning the intervention ). Method of measurement: Dual-energy X-ray absorptiometry (DXA).;Serum levels of bone turnover markers (Osteocalcin? Osteopontin, Total Alkaline Phosphatase). Timepoint: At the baseline (before intervention) and just after completion of the intervention (6 months after beginning of intervention ). Method of measurement: Using the ELISA method.;Serum levels of some inflammatory factors (TNF-a, hs-CRP, IL-6). Timepoint: At the baseline (before intervention) and just after completion of the intervention (6 months after beginning of intervention ). Method of measurement: Using calorie meter and ELISA method. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum levels of osteoporosis MicroRNA (miR422a? miR-133a? miR-21 ? miR-503). Timepoint: At the baseline (before intervention) and completion of the intervention (6 months after beginning intervention ). Method of measurement: Using the Real-Time PCR method.;Quality of life score. Timepoint: At the baseline (before intervention) and 1,3, and 6 months after beginning intervention. Method of measurement: Using the MENQOL questionnaire.;Body composition analysis score (PBF, MBF, SLM, LBM, VFM, TBW, Mineral). Timepoint: At the baseline (before intervention) and completion of the intervention (6 months after beginning intervention). Method of measurement: Body Composition Analyzer.;The 10-year probability of fracture. Timepoint: At the baseline (before intervention) and completion of intervention (6 months after beginning of study). Method of measurement: Fracture Risk Assessment Tool (FRAX).;Serum levels of some oxidative stress indices (TAC, SOD, MDA). Timepoint: At the baseline (before intervention) and just after completion of the intervention (6 months after beginning of intervention ). Method of measurement: Using Spectrophotometer and ELISA method.;Serum levels of Insulin-like Growth Factor-I and binding proteins (TAC, SOD, MDA). Timepoint: At the baseline (before intervention) and completion of intervention (6 months after beginning of study). Method of measurement: Using Spectrophotometer and ELISA method.;Lipid profile. Timepoint: At the baseline (before the intervention) and completion of the intervention (6 months after the beginning of the study). Method of measurement: biochemical methods.;Glycemic control indices. Timepoint: At the baseline (before intervention) and completion of the intervention (6 months after the beginning of the study. Method of measurement: biochemical methods.;Serum 17-ß estradiol. Timepoint: At the baseline (before intervention) and completion of the intervention (6 months after the beginning of the study. Method of measurement: Usi | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Azizeh Farshbaf-Khalili
Tabriz University of Medical Sciences
Outcome results
None listed