The study is for Korean women who are postmenopausal and also suffer from osteoporosis. The study will test if women who are given 20 mg of arzoxifene once a day for six months have a less severe level of osteoporosis than those women who do not take arzoxifene. All patients will receive 500 mg of elemental calcium and 400 to 600 IU Vitamin D daily starting 4 weeks prior to study drug administration continuing through the 6 months of therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
91
20 mg, QD, PO,24 weeks
QD, PO, 24 weeks
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bucheon-si, South Korea
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seoul, South Korea
Lumbar spine bone mineral density (BMD), by dual energy X-ray absorptiometry (DXA) analyses
Time frame: 6 months
Incidence of spontaneous vaginal bleeding.
Time frame: 6 months
Total hip BMD
Time frame: 6 months
Biochemical marker of bone metabolism (serum CTX and PINP)
Time frame: 3 and to 6 months
Overall safety of arzoxifene administration in Korean postmenopausal women
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.