The mesenchymal stem cell-derived extracellular vesicles for postmenopausal osteoporosis

Phase 1

• Conditions: Postmenopausal osteoporosis.; Osteoporosis without pathological fracture

• Registration Number: IRCT20131009014957N15
• Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 30

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.