Patients with primary hyperparathyroidism (pHPT) with osteopenia and osteoporosis are treated with strontium ranelate/Ca+Vitamin-D or placebo/Ca+Vitamin D after successful surgical treatment of pHPT. Strontium ranelate/Ca + Vitamin-D helps to regain bone mass in patients with osteopenia or osteoporosis after successful parathyroidectomy for pHPT and results in higher gain of BMD than placebo treated patients.
The chronic excessive hypersecretion of parathyroid hormone (PTH) has significant impact on bone remodeling. In primary hyperparathyroidism (PHPT) bone turnover is increased, resulting in a higher resorption of bone and thus loss of bone density. After successful surgical treatment of pHPT bone metabolism switches from catabolic state to anabolic state again. However studies show that especially postmenopausal women regain significantly less BMD but these women suffer from osteopenia and osteoporosis most often and would need to regain as much bone mass as possible to prevent fractures. The optimal state would be to reach normal BMD again. Although this state is hardly reachable especially these patients may benefit from a treatment acting anti-resorptive and rising bone formation. The only drug combining these qualities known so far is Strontium ranelate. Therefore the hypothesis is that Strontium ranelate/Ca + Vitamin-D helps to regain bone mass in patients with osteopenia or osteoporosis after successful parathyroidectomy for pHPT and results in higher gain of BMD than placebo treated patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
63
2g Strontium Ranelate once daily 1000mg Calcium 800 IE Vitamin D
Placebo 1000mg Calcium 800 IE Vitamin-D
Medical University Vienna, General Hospital Vienna (AKH Wien)
Vienna, State of Vienna, Austria
Bone mineral density measurement of the Lumbar spine
Time frame: 1 year
Bone mineral density of the femoral neck
Time frame: 1 year
Bone mineral density of the radius
Time frame: 1 year
Osteoprotegerin (OPG/OCIF)
Time frame: 1 year
RANKL (OPG-ligand)
Time frame: 1 year
cathepsin K (cat K)
Time frame: 1 year
ionised calcium (Ca++)
Time frame: 1 year
phosphate (PO4-)
Time frame: 1 year
alkaline phosphatase (AP)
Time frame: 1 year
bone-specific alkaline phosphatase (BAP)
Time frame: 1 year
osteocalcin (Oc)
Time frame: 1 year
parathyroid hormone (PTH)
Time frame: 1 year
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