The effect of Curcumin, Nigella Sativa, and Curcumin-Nigella Sativa on outcomes related to primary osteoporosis among postmenopausal wome

Phase 3

Conditions: Postmenopausal osteoporosis.
Osteoporosis without current pathological fracture

Registration Number: IRCT20131009014957N4

Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 120

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures