ABOUT THIS STUDY
- Ambulatory postmenopausal women 55 years or older at screening
- Have received daily, weekly or monthly oral bisphosphonates at least for 3 years and treatment change is indicated (not responses to bisphosphonates, for bad tolerability or for the potential risk of side effects in a long term treatment with bisphosphonates-indicated by Federal Drug Administration, European Medicines Agency.
- Subjects has stop bisphosphonates therapy no more than one month before screening visit for subjects in daily or weekly bisphosphonates
- Subjects has stop bisphosphonates therapy no more than two months before screening visit for subjects in monthly bisphosphonates
- Screening T-score at the lumbar spine ≤ -2.0 to -4.0 by Dual X ray Absorptiometry (DXA) scan
- At least 2 lumbar vertebrae must be evaluable by DXA
- Al least one hip must be evaluable by DXA (for secondary objectives)
- Any disorder that compromises the ability of the subject to give written informed
consent and/or to comply with study procedures
- Current use of medication prescribed for osteoporosis other than oral bisphosphonates
- Subjects who had received intravenous bisphosphonates or fluoride (except for dental
- Subjects who had received any Selective Estrogens Receptor Modulator (SERM), anabolic
steroids, systemic hormone replacement, calcitonin or calcitriol within 3 months.
- Subjects who had received strontium ranelate, parathyroid hormone (PTH) or PTH
derivates within 1 year.
- Hyper or hypothyroidism, current hyper or hypoparathyroidism
- History of Venous Thromboembolism Event (VTE)
- Significantly impaired renal function as determined by estimated Glomerular Filtration
Rate less 35 mL/min
- Hyper or hypocalcemia
- Vitamin D deficiency (serum 25 (OH) vit D level < 20 ng/mL (< 50nmol/L)
- Any condition that could result in impaired calcium metabolism or metabolic bone
disease that could interfere with interpretation findings
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