Osteoporosis
Conditions
Interventions
Placebo:Daily administration with 12 placebo capsules, and 500 mg calcium and 200IU Vit D
Low-dose XLGB:Daily administration with 6 active capsules plus 6 placebo capsules, 500 mg calcium and 200IU Vit D
High-dose XLGB:Daily administration with 12 active capsules, and 500 mg calcium and 200IU Vit D
Sponsors
Department of Orthopedics & Traumatology, the Chinese University of Hong Kong
Eligibility
Sex/Gender
Female
Age
58 Years to 75 Years
Inclusion criteria
Inclusion criteria: T score of bone mineral density at either lumbar spine or femoral neck in healthy postmenopausal women should be lower than -2.0SD
Exclusion criteria
Exclusion criteria: (1) previous exposure to selective estrogen receptor modulators; (2) use of hormone replacement therapy, calcitonin, sodium fluoride, anabolic steroids, chronic oral glucocorticoid, anticoagulant within the past 3 months; (3) use of bisphosphonates during the past 24 months; (4) use of parathyroid hormone during the past 6 months; (5) use of any other investigational drugs during the past month; (6) radiographic evidence of more than 3 vertebral fractures; (7) current medical disease associated with the development of metabolic bone disease; (8) T-scores of the femoral neck or lumbar spine (L1-L4) BMD more than 4.0 SD; (9) current or past history of clinically significant hematological, endocrinological, cardiovascular, renal, hepatic, gastrointestinal, psychiatric, or neurological diseases or drug allergies to estrogen-like hormonal drugs; (10) history of fracture of the lumbar spine (L1-L4), scoliosis, osteoarthritis, or other clinical spinal deformity which would interfere with BMD measurement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Side events;Lumbar spine BMD; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum osteocalcine;Muscle function;Quality of Life score;Serum E2;Balance;Serum CTX-I;Femoral Neck BMD; | — |
Countries
France
Contacts
Public ContactQin Ling, Zhu Hanmin
Outcome results
None listed