The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of patients with osteoporosis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
4,665
0.8mg SMC021 - oral calcitonin, once daily
SMC021 - Placebo, once daily
United Osteporosis Centers
Gainesville, Georgia, United States
Michigan Bone & Mineral Clinic PC,
Detroit, Michigan, United States
Oregon Osteoporosis Center
Portland, Oregon, United States
Number of Patients With New Vertebral Fractures
The primary variable was the occurrence or not of a new vertebral fracture during the 3 year observation period. New vertebral fractures were identified from an assessment of x-ray of the lateral spine through time (at baseline and at yearly intervals thereafter). The outcome is the number of new vertebral fractures from baseline to 36 months.
Time frame: From baseline to month 36
Number of Patients With Non-vertebral Fractures
The secondary outcome was the occurrence or not of a non-vertebral fracture during the 3 year observation period. Non-vertebral fractures of interest were: hip fractures, forearm fractures, humurus fractures, rib fractures and clavicular fractures. Any new non-vertebral fractures while on-study were recorded. A copy of radiographs confirming the fracture, as well as a copy of the radiologist's report was to be obtained. A copy of the emergency room discharge letter or a hospital discharge letter was also obtained.
Time frame: From baseline to month 36
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CCBR Brazil
Rio de Janeiro, Brazil
CCBR China
Beijing, China
CCBR Czech
Pardubice, Czechia
CCBR Aalborg
Aalborg, Denmark
CCBR Ballerup
Ballerup Municipality, Denmark
CCBR Vejle
Vejle, Denmark
CCBR Estonia
Tallinn, Estonia
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