Postmenopausal osteoporosis. Osteoporosis without pathological fracture
Conditions
Interventions
Intervention 1: Intervention group 1: Receiving intravenous extracellular vesicles derived from stem cells Mesenchymal (MSCs-EV) together with alendronate sodium tablets 70 mg once a week until the en
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
50 Years to 70 Years
Inclusion criteria
Inclusion criteria: Having the ability to self-care A resident of Tabriz city Cessation of menstruation for at least 12 consecutive months Having a bone density of less than 2.5 in the lumbar vertebrae, pelvis, or femoral neck No history of fracture
Exclusion criteria
Exclusion criteria: T-score=-4 in lumbar vertebrae, T-score=-3.5 in pelvic bone and femoral neck, history of hip or vertebrae fractures Suffering from renal failure and diseases Having bone diseases other than osteoporosis Taking drugs that affect bone metabolism Having a mental illness according to the patient's own statement Malignancy according to the patient's own statement Peptic ulcers and malabsorption disorders 25-(OH) Vitamin D levels < 20ng/ml or current hypercalcemia or hypocalcemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate and severity of adverse events in the study groups. Timepoint: During one year of intervention. Method of measurement: Through recording in the questionnaire and phone calls.;The rate of enrollment and retention of participants in study groups. Timepoint: During one year of intervention. Method of measurement: Researcher's own follow-up.;Changes in the levels of some inflammatory and anti-inflammatory factors (TNF-a, HS-CRP, IL-10 and IL-6). Timepoint: The beginning and end of the intervention. Method of measurement: Using biochemical methods.;Changes in the levels of serum bone resorption markers (osteocalcin, P1NP, BSAP, CTX). Timepoint: The beginning and end of the intervention. Method of measurement: Using biochemical methods and ELISA kit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in bone density (T-score, BMD Z-score). Timepoint: The beginning and end of the intervention. Method of measurement: Using a densitometry device.;Changes in the levels of some oxidative stress factors (TAC, SOD, MDA). Timepoint: The beginning and end of the intervention. Method of measurement: Using biochemical methods.;Nutritional status (appetite status, average weight, BMI, waist circumference, ratio of waist circumference to hip circumference). Timepoint: The beginning, middle and end of the intervention. Method of measurement: Questionnaire and anthropometric methods. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAzizeh Farshbaf-Khalili
Tabriz University of Medical Sciences
Outcome results
None listed