Evaluating the effects of pine bark extract supplementation in postmenopausal osteopenic wome

Phase 2

• Conditions: Osteopenia.; Postmenopausal osteoporosis

• Registration Number: IRCT2015071123153N1
• Lead Sponsor: Tehran University of Medical Sciences, Vice Chancellor of Research, International Campus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Other
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

Postmenopausal women; Age: between 50-65 years; With a diagnosis of osteopenia. Osteopenia was defined as bone mineral density T-score at the spine and/or hip between 1 to 2.5 SD below the young normal ex-matched areal BMD of the reference database (According to the WHO); Normal function of thyroid, liver, and kidney.
Exclusion criteria: Report of fractures during the study; unwilling to continue participate in the project; Any visible side effects of supplements; The history of bone disease (Paget's disease, osteomalacia, etc.); History of chronic diseases, including cancer, diabetes, kidney failure, liver disease, systemic inflammatory disease, degenerative joint diseases and rheumatologic disorders;

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Procollagen type I N-terminal propeptide (PINP). Timepoint: Before the intervention and immediately after the intervention. Method of measurement: ELISA.;Cross-Linked Carboxy-Terminal Telopeptide of Type I Collagen. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: ELISA.;Bone alkaline phosphatase (BAP). Timepoint: Before the intervention and immediately after the intervention. Method of measurement: ELISA.;Receptor activator of nuclear factor kappa-B ligand (RANKL). Timepoint: Before the intervention and immediately after the intervention. Method of measurement: ELISA.;Osteoprotegerin (OPG). Timepoint: Before the intervention and immediately after the intervention. Method of measurement: ELISA.

Secondary Outcome Measures

Name	Time	Method
Weight. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: digital scale.