This study is designed to provide information about the bone-anabolic response of PTH134 when administered orally, in comparison to Forsteo®, the sub-cutaneous form of teriparatide, the active ingredient in PTH134.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
104
Novartis Investigative Site
Aalborg, Denmark
Novartis Investigative Site
Ballerup Municipality, Denmark
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Munich, Germany
Measure: Effects of treatment on bone biomarkers. Measure levels of PINP, CTX-1, and serum calcium levels, serum phosphate, P1CP, bone-specific alkaline phosphatase, osteocalcin.
Time frame: 12 weeks
Change from baseline in serum calcium levels after 12 weeks of treatment
Time frame: 12 weeks
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