Renal Insufficiency
Conditions
Keywords
bone density, osteopenia, transplant, zoledronic acid, alendronate
Brief summary
The study is designed to look at the effect of different bone treatment plans on bone loss after kidney or kidney/pancreas transplant.
Detailed description
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.
Interventions
DRUGZoledronic Acid
4mg IV Annually
COMBINATION_PRODUCTCalcium with vitamin D
1200 mg Calcium with 800 International Units of vitamin D
DRUGAlendronate
70mg weekly
Sponsors
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Transplant patients who have had a kidney or kidney/pancreas transplant in the last 150 days with adequate kidney function as defined by a calculated creatine clearance of 35ml/min or more and serum creatinine less than 3.0
Exclusion criteria
* Dual X-ray Absorptiometry (DXA) T-score at the spine or hip of -3 or lower * History of more than one vertebral or non-vertebral fracture in the past two years * Abnormalities of the esophagus which delay esophageal emptying * Inability to stay upright for 30 minutes * Pregnant, nursing women or women not using an effective form of birth control * Hypocalcemia * Hypercalcemia * Calculated creatinine clearance of \<35 ml/min or serum creatinine \> 3.0 * Patients already treated with bisphosphonates within the past one year * Patients unable to undergo DXA * Patients with cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant | 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compliance With Zoledronic Acid, Alendronate and/or Calcium/Vitamin D Supplementation | 24 months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Intravenous Bisphosphonate Post Transplantation Zoledronic Acid 4mg
Zoledronic Acid: 4mg IV Annually | 24 |
| Oral Bisphosphonate Post Tranpslantation Alendronate 70mg
Alendronate: 70mg weekly | 23 |
| Placebo Post Transplantation Calcium 1200mg Vitamin D 800IU
calcium and Vitamin D: 1200 mg Calcium 800 International Units Vitamin D | 12 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 2 |
Baseline characteristics
| Characteristic | Total | Intravenous Bisphosphonate Post Transplantation | Placebo Post Transplantation | Oral Bisphosphonate Post Tranpslantation |
|---|---|---|---|---|
| Age, Continuous | 47 years STANDARD_DEVIATION 12 | 47 years STANDARD_DEVIATION 11 | 46 years STANDARD_DEVIATION 12 | 50 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 59 Participants | 24 Participants | 12 Participants | 23 Participants |
| Sex: Female, Male Female | 20 Participants | 11 Participants | 2 Participants | 7 Participants |
| Sex: Female, Male Male | 39 Participants | 13 Participants | 10 Participants | 16 Participants |
| Spine bone density | 1.3 grams/cm2 STANDARD_DEVIATION 0.05 | 1.5 grams/cm2 STANDARD_DEVIATION 0.03 | 1.12 grams/cm2 STANDARD_DEVIATION 0.05 | 1.28 grams/cm2 STANDARD_DEVIATION 0.046 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 23 | 0 / 12 |
| other Total, other adverse events | 2 / 24 | 4 / 23 | 2 / 12 |
| serious Total, serious adverse events | 0 / 24 | 0 / 23 | 0 / 12 |
Outcome results
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.
Time frame: 24 months
Population: Percentage change in spine bone density from baseline to 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intravenous Bisphosphonate Post Transplantation | Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant | 8.1 percentage of change of bone density |
| Oral Bisphosphonate Post Transplantation | Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant | 6.6 percentage of change of bone density |
| Placebo Group Post Transplantation | Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant | 6.5 percentage of change of bone density |
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.
Time frame: 24 months
Population: Compliance in study arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intravenous Bisphosphonate Post Transplantation | Compliance With Zoledronic Acid, Alendronate and/or Calcium/Vitamin D Supplementation | 100 percentage of compliance |
| Oral Bisphosphonate Post Transplantation | Compliance With Zoledronic Acid, Alendronate and/or Calcium/Vitamin D Supplementation | 80 percentage of compliance |
| Placebo Group Post Transplantation | Compliance With Zoledronic Acid, Alendronate and/or Calcium/Vitamin D Supplementation | 80 percentage of compliance |