This study is being conducted to compare the effect of increasing nasal teriparatide dosing on percent change in Bone Mineral Density (BMD) of the lumbar spine after 24 weeks of therapy in postmenopausal women with low bone mineral density.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
350
20ug subcutaneous injection daily for 24 weeks
teriparatide intranasally daily for 24 weeks
teriparatide intranasally daily for 24 weeks
Change in bone mineral density of the lumbar spine from baseline to 24 weeks post treatment.
Time frame: 24 weeks
Change in bone mineral density from baseline to 12 weeks post treatment
Time frame: 12 weeks
Safety, including hypercalcemia and nasal effects
Time frame: 24 weeks
Change from baseline in bone markers PINP and CTX from baseline to 4, 12 and 24 weeks post treatment
Time frame: 4, 12 and 24 weeks
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teriparatide intranasally daily for 24 weeks
teriparatide intranasally daily for 24 weeks