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 study is designed to look at the effect of different bone treatment plans on bone loss after kidney or kidney/pancreas transplant.
The aims are to determine baseline bone mineral density (BMD) in kidney and kidney/pancreas transplant patients who will be randomized to weekly alendronate, annual zoledronic acid infusions or placebo (calcium with Vitamin D). These patients will be followed for two years with annual bone density testing as well as biochemical markers. A secondary aim is to evaluate the compliance.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Zoledronic Acid | Active Comparator | Zoledronic Acid 4mg intravenously once a year for 2 years |
|
| 2 Alendronate | Active Comparator | Alendronate 70mg orally once a week for 2 years |
|
| 3 Placebo | Placebo Comparator | Combination drug entity: calcium 1200 mg with vitamin D 800 International Units daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic Acid | Drug | 4mg IV Annually |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant | Posterior Anterior (PA) spine bone density was measured by dual energy x-ray absorptiometry (DXA) at baseline and 24 months post transplant. The percentage change in the PA spine bone density was then compared from baseline to 24 months post transplant. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance With Zoledronic Acid, Alendronate and/or Calcium/Vitamin D Supplementation | Compare compliance where a study coordinator interviewed patients as to how often they missed the once a week oral alendronate, missed taking calcium and vitamin D supplementation, or missed the once a year IV Reclast. | 24 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lynn Mack, MD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26733377 | Background | Wang J, Yao M, Xu JH, Shu B, Wang YJ, Cui XJ. Bisphosphonates for prevention of osteopenia in kidney-transplant recipients: a systematic review of randomized controlled trials. Osteoporos Int. 2016 May;27(5):1683-90. doi: 10.1007/s00198-015-3465-7. Epub 2016 Jan 5. | |
| 23024190 | Background | Shane E, Cohen A, Stein EM, McMahon DJ, Zhang C, Young P, Pandit K, Staron RB, Verna EC, Brown R, Restaino S, Mancini D. Zoledronic acid versus alendronate for the prevention of bone loss after heart or liver transplantation. J Clin Endocrinol Metab. 2012 Dec;97(12):4481-90. doi: 10.1210/jc.2012-2804. Epub 2012 Sep 28. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants were recruited during the transplant hospitalization or within 30 days of transplantation. They were excluded if they had an esophageal abnormality, bone density T-score of -3 or lower, fracture in the last 2 years, Cr Cl of 35 or less, inability to sit upright for 30 minutes after swallowing a medication.
All patients from the Kidney Pancreas Transplant clinic at the University of Nebraska Medical Center who underwent a kidney, pancreas, or kidney-pancreas transplant from 2003 to 2009 were invited to participate.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous Bisphosphonate Post Transplantation | Zoledronic Acid 4mg Zoledronic Acid: 4mg IV Annually |
| FG001 | Oral Bisphosphonate Post Transplantation | Alendronate 70mg Alendronate: 70mg weekly |
| FG002 | Placebo Group Post Transplantation | Calcium 1200mg Vitamin D 800IU calcium and Vitamin D: 1200 mg Calcium 800 International Units Vitamin D |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Men and women post kidney or kidney pancreas transplantation
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous Bisphosphonate Post Transplantation | Zoledronic Acid 4mg Zoledronic Acid: 4mg IV Annually |
| BG001 | Oral Bisphosphonate Post Tranpslantation | Alendronate 70mg Alendronate: 70mg weekly |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant | Posterior Anterior (PA) spine bone density was measured by dual energy x-ray absorptiometry (DXA) at baseline and 24 months post transplant. The percentage change in the PA spine bone density was then compared from baseline to 24 months post transplant. | Percentage change in spine bone density from baseline to 24 months | Posted | Number | percentage of change of bone density | 24 months |
|
2 years
A study coordinator helped the patient complete a questionnaire of potential side effects/adverse events
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intravenous Bisphosphonate After Tranpslant | Zoledronic Acid 4mg Zoledronic Acid: 4mg IV Annually |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dyspepsia | Gastrointestinal disorders | Systematic Assessment |
Small sample sizes and missing data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lynn Mack | University of Nebraska Medical Center | 402-559-6208 | lmack@unmc.edu |
Not provided
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| D002118 | Calcium |
| D014807 | Vitamin D |
| D019355 | Calcium Citrate |
| D002119 | Calcium Carbonate |
| D019386 | Alendronate |
| 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
| Calcium with vitamin D | Combination Product | 1200 mg Calcium with 800 International Units of vitamin D |
|
|
| Alendronate | Drug | 70mg weekly |
|
|
| Withdrawal by Subject |
|
| BG002 | Placebo Post Transplantation | Calcium 1200mg Vitamin D 800IU calcium and Vitamin D: 1200 mg Calcium 800 International Units Vitamin D |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Spine bone density | mean spine bone density in g/cm2 | Mean | Standard Deviation | grams/cm2 |
|
Alendronate 70mg
Alendronate: 70mg weekly
8% increase
| OG002 | Placebo Group Post Transplantation | Calcium 1200mg Vitamin D 800IU calcium and Vitamin D: 1200 mg Calcium 800 International Units Vitamin D 8% increase |
|
|
| Secondary | Compliance With Zoledronic Acid, Alendronate and/or Calcium/Vitamin D Supplementation | Compare compliance where a study coordinator interviewed patients as to how often they missed the once a week oral alendronate, missed taking calcium and vitamin D supplementation, or missed the once a year IV Reclast. | Compliance in study arm | Posted | Number | percentage of compliance | 24 months |
|
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 2 |
| 24 |
| EG001 | Oral Bisphosphonate After Transplant | Alendronate 70mg Alendronate: 70mg weekly | 0 | 23 | 0 | 23 | 4 | 23 |
| EG002 | Placebo After Transplant | Calcium 1200mg Vitamin D 800IU calcium and Vitamin D: 1200 mg Calcium 800 International Units Vitamin D | 0 | 12 | 0 | 12 | 2 | 12 |
| muscle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | Systematic Assessment |
|
| flatulence | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D017610 | Calcium Compounds |
| D019343 | Citric Acid |
| D002951 | Citrates |
| D014233 | Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |