This is a multi-center, randomized, open-label, TPTD-controlled study in postmenopausal
women with osteoporosis at high risk for fracture.
Minimum age: 55 Years.
Maximum age: 90 Years.
Gender(s): Female.
Inclusion Criteria:
- Postmenopausal women, aged ≥ 60 to ≤ 90.
- Received oral bisphosphonate therapy for at least 3 years immediately prior to
screening
- BMD T-score ≤ -2. 50 at the lumbar spine, total hip or femoral neck
- History of nonvertebral fracture after age 50, or vertebral fracture.
Exclusion Criteria:
- Use of other agents affecting bone metabolism including Strontium ranelate, fluoride
(for osteoporosis), odanacatib (MK-0822) or any other cathepsin K inhibitor, IV
bisphosphonates, Denosumab, TPTD or any PTH analogs, Systemic oral or transdermal
estrogen, SERMs, activated vitamin D3, vitamin K2, calcitonin, Tibolone, cinacalcet,
Systemic glucocorticosteroids:
- History of metabolic or bone disease (except osteoporosis) that may interfere with
the interpretation of study results, such as sclerosteosis, Paget's disease,
rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis,
ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption
syndrome -
- Vitamin D insufficiency, defined as 25 (OH) vitamin D levels < 20 ng/mL, as
determined by the central laboratory.
- Current hyper- or hypocalcemia
- Current, uncontrolled hyper- or hypothyroidism
Research Site, Genk 3600, Belgium
Research Site, Gent 9000, Belgium
Research Site, Leuven 3000, Belgium
Research Site, Liege 1 4000, Belgium
Research Site, Quebec G1V 3M7, Canada
Research Site, Brno 602 00, Czech Republic
Research Site, Ostrava 1 702 00, Czech Republic
Research Site, Plzen 305 99, Czech Republic
Research Site, Praha 11 - Chodov 148 00, Czech Republic
Research Site, Uherske Hradiste 686 01, Czech Republic
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Research Site, Esbjerg 6700, Denmark
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Research Site, Madrid 28041, Spain
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Research Site, Ciudad Autonoma de Buenos Aires, Buenos Aires C1012AAR, Argentina
Research Site, Ciudad Autonoma de Buenos Aires, Buenos Aires C1128AAF, Argentina
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Research Site, LHospitalet de Llobregat, Cataluña 08907, Spain
Research Site, Cordoba, Córdoba X5000BNB, Argentina
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Research Site, Toronto, Ontario M5G 2C4, Canada