Systematic Treatment After Successful Surgical Treatment for Primary Hyperparathyroidism With Strontium Ranelate
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|ClinicalTrials.gov Identifier: NCT01222026|
Recruitment Status : Completed
First Posted : October 18, 2010
Last Update Posted : January 21, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Primary Hyperparathyroidism Osteopenia Osteoporosis||Drug: Strontium Ranelate + Ca/Vitamin-D Drug: Placebo||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium- and Bone Metabolism After Successful Surgery? - Part I|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|