Postmenopausal women Osteopenia Menopause Osteopenia Phytotherapy Bone Vitaceae
Conditions
Interventions
starch capsule,Cissus quadrangularis L. 300 mg/capsule ,Cissus quadrangularis L. 400 mg/capsule
Placebo,CQ1.2,CQ1.6
Sponsors
Faculty of Pharmacy, Mahidol University
Chao Phya Abhaibhubejhr Hospital
Eligibility
Sex/Gender
Female
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) The postmenopausal women aged more than 40 years old (2) Participant with 1 -10 years since menopause (3) Participant with estradiol less than 35 pg/mL and (4) Participant with FSH more than 30 mIU/mL (5) Participant with osteopenia at lumbar spine, femoral neck, or total hip
Exclusion criteria
Exclusion criteria: (1) Participant with underlining disease that affects to bone remodeling process, e.g., thyroid disorder, parathyroid disorder, rheumatoid arthritis (2) Receiving medications that affect bone metabolism, e.g., glucocorticoid, anticoagulation, anticonvulsant, steroid, immunosuppressive agent, antiepileptic, aromatase inhibitor, GnRH antagonist, SSRI, thiazolidinedione, calcineurin inhibitor, and chemotherapy (3) serum AST more than 40 U/L (4) serum ALT more than 40 U/L (5) serum creatinine more than 1.3 or less than 0.4 mg/dL (6) eGFR less than 60 ml/min per 1.73 m2 (7) Participant with a history of decreasing height more than 4 cm (8) Participant with a 10-year probability of hip fracture more than 3% or other major osteoporotic fractures more than 20%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of bone mineral density Day 0 and Day 180 Dual-energy x-ray absorptiometry (DEXA) scan | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of biochemical markers Day 0, Day 90, and Day 180 electro chemiluminescence immunoassay,Adverse event Day 0, Day 30, Day 90, and Day 180 liver function test, kidney function test, naranjo algorithm | — |
Countries
Thailand
Contacts
Public ContactSaksit Benjawan
Faculty of Pharmacy, Mahidol University.
Outcome results
None listed