Osteoporosis Clinical Trial
Official title:
Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium- and Bone Metabolism After Successful Surgery? - Part I
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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