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Low bone mineral density (BMD) is commonly reported in patients receiving home parenteral nutrition (HPN). Denosumab represent a new drug, which helped to prevent osteoclast. The aim of the study was to assess its value in chronic intestinal failure patients.
Low bone mineral density (BMD) is commonly reported in patients receiving home parenteral nutrition (HPN). Oral and intravenous calcium, vitamin D and bisphosphonates have been commonly used to treat BMD, but their efficiency is may be inadequate due to limited absorption and compliance. Denosumab represent a new drug, which helped to prevent osteoclast development and activation, hence decreased bone resorption in some studies. The aim of the study was to assess its value in chronic intestinal failure patients receiving HPN.
Between November 2011 and March 2013 denosumab was administered to 16 HPN patients (9 F, 7 M mean age 55.4) with intestinal failure. Regional dual-energy x-ray absorptiometry of spine and hip were performed before the therapy was initiated, and after 12 months. BMD, T-score and Z-score were measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Denosumab | Experimental | One per 6 months subcutaneous injection of Denosumab (2 doses in total) |
|
| No Denosumab | No Intervention | No intervention, just observation of HPN patients |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denosumab | Drug | Subcutaneous injection of Denosumab |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of bone structure: Spine | The increase of spine bone density measured by the change of Standard Deviation (SD) measured by DEXA at the level L1-L4 | 36 months |
| Improvement of bone structure: Femur | The increase of femur bone density measured by the change of Standard Deviation (SD) measured by DEXA at femur trochanter and shaft | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment tolerance: gastrointestinal | The presence of adverse events from gastrointestinal tract: nausea, vomiting, diarhhoea | 36 months |
| Treatment tolerance: bone pain | The presence of bone pain assessed with VAS score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanley Dudrick's Memorial Hospital | Skawina | 32-050 | Poland |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 36 months |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |