Renal InsufficiencyNCT00580047
Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplants
A study testing Zoledronic Acid, Calcium with vitamin D and Alendronate in people with Renal Insufficiency, run by University of Nebraska at 1 site in United States.
Trial summary
The study is designed to look at the effect of different bone treatment plans on bone loss after kidney or kidney/pancreas transplant. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- Zoledronic Acid, Calcium with vitamin D and Alendronate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2003to 29 Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplant
The study is designed to look at the effect of different bone treatment plans on bone loss after kidney or kidney/pancreas transplant.
Read the 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.
- Conditions
- Renal Insufficiency
- Being tested
- Zoledronic Acid, Calcium with vitamin D, Alendronate
- Keywords
- bone density, osteopenia, transplant, zoledronic acid, alendronate
- Medical subject headings
- Renal Insufficiency, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic AcidDrug
Also called Zometa
4mg IV Annually
Calcium with vitamin DCombination product
Also called calcium citrate, calcium carbonate
1200 mg Calcium with 800 International Units of vitamin D
AlendronateDrug
Also called Fosamax
70mg weekly
| Study group | Role | What they receive |
|---|---|---|
| 1 Zoledronic Acid | Active comparator | Zoledronic Acid 4mg intravenously once a year for 2 years Receives: Drug: Zoledronic Acid |
| 2 Alendronate | Active comparator | Alendronate 70mg orally once a week for 2 years Receives: Drug: Alendronate |
| 3 Placebo | Placebo comparator | Combination drug entity: calcium 1200 mg with vitamin D 800 International Units daily Receives: Combination Product: Calcium with vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (1)
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study start1 Dec 2003
- Primary completion29 Jul 2014
- Study completion29 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lynn Mack, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580047
- Sponsor's protocol ID
- 0437-02-FB
- Status last verified
- Sep 2023
- First submitted
- 17 Dec 2007
- Last updated
- 4 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26733377Shane 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.
PubMed 23024190
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplant
- ClinicalTrials.gov ID
- NCT00580047
- Acronym / sponsor ID
- 0437-02-FB
- Conditions
- Renal Insufficiency
- Keywords
- bone density, osteopenia, transplant, zoledronic acid, alendronate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Dec 2003 (actual)
- Primary completion
- 29 Jul 2014 (actual)
- Study completion
- 29 Jul 2014 (actual)
- First posted
- 24 Dec 2007 (estimated)
- Results
- Posted 19 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 Zoledronic Acid | Active comparator | Drug: Zoledronic AcidZoledronic Acid 4mg intravenously once a year for 2 years |
| 2 Alendronate | Active comparator | Drug: AlendronateAlendronate 70mg orally once a week for 2 years |
| 3 Placebo | Placebo comparator | Combination Product: Calcium with vitamin DCombination drug entity: calcium 1200 mg with vitamin D 800 International Units daily |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic AcidAlso: Zometa4mg IV Annually | Drug | 1 Zoledronic Acid |
| Calcium with vitamin DAlso: calcium citrate, calcium carbonate1200 mg Calcium with 800 International Units of vitamin D | Combination product | 3 Placebo |
| AlendronateAlso: Fosamax70mg weekly | Drug | 2 Alendronate |
Primary outcome
Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant
Time frame: 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.
1 secondary outcome
Compliance With Zoledronic Acid, Alendronate and/or Calcium/Vitamin D Supplementation
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26733377Wang 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.
- Background: PubMed 23024190Shane 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynn Mack, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zoledronic Acid, Calcium with vitamin D and Alendronate in people with Renal Insufficiency, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00580047, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.