Investigators will prospectively include 40 postmenopausal women with secondary osteoporosis due to primary hyperparathyroidism who have refused surgery. Participants will be randomized in two groups and treated either with zoledronic acid 5 mg iv once a year or with denosumab 60 mg sc every 6 months. Investigators will compare the effect of both drugs on bone turnover markers and basic laboratory parameters after 3, 12 and 24 months of treatment, and on the bone mineral density after 12 and 24 months of treatment. All participants will take cholecalciferol 800 - 1000 IU daily.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
denosumab 60 mg subcutaneously every 6 months
zoledronic acid 5 mg intravenously once a year
Endocrinology Department
Ljubljana, Slovenia
Bone mineral density after one year of treatment
Dual-energy X-ray absorptiometry (DXA)
Time frame: one year
CTX after 3 months of treatment
Unit of Measure: pmol/L
Time frame: 3 months
Corrected calcium after 3 months of treatment
Unit of Measure: mmol/L
Time frame: 3 months
Bone mineral density after two years of treatment
Dual-energy X-ray absorptiometry (DXA)
Time frame: two years
CTX after 12 months of treatment
Unit of Measure: pmol/L
Time frame: one year
CTX after 24 months of treatment
Unit of Measure: pmol/L
Time frame: two years
PINP after 3 months of treatment
Unit of Measure: µg/L
Time frame: 3 months
PINP after 12 months of treatment
Unit of Measure: µg/L
Time frame: one year
PINP after 24 months of treatment
Unit of Measure: µg/L
Time frame: two years
Bone-specific alkaline phosphatase (BAP) after 3 months of treatment
Unit of Measure: µg/L
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Time frame: 3 months
Bone-specific alkaline phosphatase (BAP) after 12 months of treatment
Unit of Measure: µg/L
Time frame: one year
Bone-specific alkaline phosphatase (BAP) after 24 months of treatment
Unit of Measure: µg/L
Time frame: two years
Corrected calcium after 12 months of treatment
Unit of Measure: mmol/L
Time frame: one year
Corrected calcium after 24 months of treatment
Unit of Measure: mmol/L
Time frame: two years