Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011/22962-3 | Other Grant/Funding Number | FAPESP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether zolendronic acid, a third generation bisphosphonate, is effective in preventing bone loss in the first year after kidney transplantation.
For the treatment of osteoporosis in the general population, a number of drugs reduce BMD (bone mineral density) loss and the rate of incident fractures. For instance, bisphosphonates improve BMD, reduce hip fracture rates and decrease mortality in post-menopausal women. Because of lack of data on safety and an increased risk of adverse effects, the use of these drugs is controversial in patients with chronic kidney disease (CKD) and abnormalities of PTH or vitamin D, an estimated glomerular filtration rate (GFR) less than 30 ml/min/1.73m² (CKD stages 4 and 5) and after transplantation. The efficacy of short and long term bisphosphonate treatment after kidney transplantation has been examined; however, histomorphometric and fracture rate reduction data are lacking.
The purpose of this study is to determine whether zolendronic acid, a third generation bisphosphonate, is effective in preventing bone loss in the first year after kidney transplantation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zoledronic acid | Experimental | Intravenous administration of zoledronic acid (5 mg) in a single dose at the time of kidney transplantation and vitamin D replacement. |
|
| Control | No Intervention | The control group will receive only vitamin D replacement. The aim of vitamin D replacement will be serum levels of 25 (OH) vitamin D above 30 ng/ml. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic acid | Drug | The treatment group will receive 15-minute intravenous administration of zoledronic acid (5 mg) in a single dose at the time of kidney transplantation and vitamin D replacement. The aim of vitamin D replacement will be serum levels of 25 (OH) vitamin D above 30 ng/ml. |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in bone turnover | Bone histomorphometric data will be analyzed at baseline and after 1 year of kidney transplantation. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Bone microarchitecture | Bone microarchitecture will be examined by high-resolution peripheral quantitative computed tomography at the time of transplant and after 12 months. | 1 year |
| Changes in Bone Mineral Density |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elias David-Neto, MD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clinicas - Faculdade de Medicina da Universidade de São Paulo | São Paulo | São Paulo | 05403-900 | Brazil |
Not provided
| ID | Term |
|---|---|
| D012080 | Chronic Kidney Disease-Mineral and Bone Disorder |
| D001847 | Bone Diseases |
| ID | Term |
|---|---|
| D012279 | Rickets |
| D001851 | Bone Diseases, Metabolic |
| D009140 | Musculoskeletal Diseases |
| D007674 | Kidney Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
Bone mineral density (BMD) measurements by dual-energy X-ray absorptiometry (DEXA) will be made at the time of transplant and after 6 and 12 months.
| 1 year |
| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002128 | Calcium Metabolism Disorders |
| D014808 | Vitamin D Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D006962 | Hyperparathyroidism, Secondary |
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |