A Clinical Study of a Standardized Extract of Leaves of (Roxb ex DC) in Postmenopausal Osteoporosis.

CONTEXT

had shown anti-osteoporotic and fracture-healing activities in animal models of postmenopausal osteoporosis (PMO). Standardized extract of leaves of (SEL-Ds) was clinically evaluated for osteoporosis.

AIMS

To investigate the anti-osteoporotic activity of in PMO by dual-energy X-ray absorptiometry (DXA), biochemical markers, and effect on clinical profile. Tolerability was assessed by organ function tests and adverse events.

SETTINGS AND DESIGN

An open-labeled prospective clinical study in ambulant settings was conducted at the menopausal health-care facility of a women's hospital.

MATERIALS AND METHODS

Thirty women (45-69 years) were enrolled for this 1-year study. Evaluations were basally, fortnightly twice, and three monthly four times. SEL-Ds (300 mg) twice daily was administered orally. Calcium (250 mg) and Vitamin D (200 IU) were given twice a day. The efficacy of SEL-Ds was assessed by DXA-scan (spine, femur), by biochemical markers, alkaline phosphatase (ALP), tumor necrosis factor-alpha (TNF-α), and anti-inflammatory marker high-sensitivity C-reactive protein (hs-CRP). Baseline symptom changes and adverse events were carefully recorded.

STATISTICAL ANALYSIS

Summary statistics (n, mean, standard deviation, median, and maximum and minimum values) of changes from baseline values and Student's "t-" test for values were used.

RESULTS AND DISCUSSION

SEL-Ds was well tolerated at given dose for 1 year. Anti-osteoporotic and anti-inflammatory activities of SEL-Ds were demonstrated by reduction in TNF-α (12.04 ± 2.81-2.35 ± 1.08 pg/ml), ALP (208.75 ± 45.88-154.52 ± 37.25 IU/L), and hs-CRP (6.1 ± 0.77-3.9 ± 0.47 mg/L). BMD-score on DXA-scan also remained unchanged at majority of the bone locations (increased 13/75, unchanged 51/75, and decreased 08/75).

CONCLUSIONS

has demonstrated anti-osteoporotic and anti-inflammatory activities as indicated by decline in circulating TNF-α along with concurrent reduction in ALP. The nondecline in BMD index in the majority confirms the anti-osteoporotic activity.