Assessment of the effects of pine bark extract supplementation on bone turnover and the possible mechanism through OPG/RANKL signaling in postmenopausal osteopenic women: A clinical trial protocol

Despite the high prevalence of osteopenia in post-menopausal women, the treatment of osteopenia is controversial. This study aims to evaluate the effects of Pine Bark Extract (PBE) supplementation on bone turnover in postmenopausal osteopenic women.

This randomized double-blind clinical trial will be conducted in postmenopausal osteopenic women in Shariati Hospital of Tehran University of Medical Sciences. Totally, 44 postmenopausal women with osteopenia were randomly recruited into two study groups; in Pine Bark Extraction supplementation (250 mg/d, n=22) or placebo (n=22). For the demographic data of all subjects, the past medical history which is a recorded measurement of bone turn-over markers (PINP, BAP, CTx and OPG/RANKL) will be determined before and after the intervention.

The research was performed after obtaining approval from the Ethics Committee of Tehran University of Medical Sciences (IR.TUMS.VCR.REC.1395.1408), in line with the Helsinki Declaration. Prior to the commencement of the study, a written informed consent form was signed and dated by participants and investigators. The results will be released at the right time.