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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001703-32 | EudraCT Number |
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| Name | Class |
|---|---|
| National Bank of Austria | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strontium Ranelate | Active Comparator | Receiving Strontium Ranelate + Ca/Vitamin-D |
|
| Placebo | Placebo Comparator | Receiving Placebo + Ca/Vitamin D |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strontium Ranelate + Ca/Vitamin-D | Drug | 2g Strontium Ranelate once daily 1000mg Calcium 800 IE Vitamin D |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone mineral density measurement of the Lumbar spine | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Bone mineral density of the femoral neck | 1 year | |
| Bone mineral density of the radius | 1 year | |
| Osteoprotegerin (OPG/OCIF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno Niederle, Prof., MD | Section of Endocrine Surgery, Department of Surgery, Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Vienna, General Hospital Vienna (AKH Wien) | Vienna | State of Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D049950 | Hyperparathyroidism, Primary |
| D001851 | Bone Diseases, Metabolic |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D001847 | Bone Diseases |
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| ID | Term |
|---|---|
| C081587 | strontium ranelate |
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| Placebo | Drug | Placebo 1000mg Calcium 800 IE Vitamin-D |
|
| 1 year |
| RANKL (OPG-ligand) | 1 year |
| cathepsin K (cat K) | 1 year |
| ionised calcium (Ca++) | 1 year |
| phosphate (PO4-) | 1 year |
| alkaline phosphatase (AP) | 1 year |
| bone-specific alkaline phosphatase (BAP) | 1 year |
| osteocalcin (Oc) | 1 year |
| parathyroid hormone (PTH) | 1 year |
| D009140 |
| Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |