Systematic Treatment After Successful Surgical Treatment for Primary Hyperparathyroidism With Strontium Ranelate
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.
|Primary Hyperparathyroidism Osteopenia Osteoporosis||Drug: Strontium Ranelate + Ca/Vitamin-D Drug: Placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium- and Bone Metabolism After Successful Surgery? - Part I|
- 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 ]
|Study Start Date:||September 2010|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Strontium Ranelate
Receiving Strontium Ranelate + Ca/Vitamin-D
Drug: Strontium Ranelate + Ca/Vitamin-D
2g Strontium Ranelate once daily 1000mg Calcium 800 IE Vitamin D
Other Name: Protelos (r)
Placebo Comparator: Placebo
Receiving Placebo + Ca/Vitamin D
Placebo 1000mg Calcium 800 IE Vitamin-D
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01222026
|Medical University Vienna, General Hospital Vienna (AKH Wien)|
|Vienna, Austria, 1090|
|Principal Investigator:||Bruno Niederle, Prof., MD||Section of Endocrine Surgery, Department of Surgery, Medical University of Vienna|