End-Stage Renal DiseasePhase 4NCT00261625
Can Alendronate Suppress Calcification and Improve Bone Density in Chronic Peritoneal Dialysis Patients?
A Phase 4 study testing alendronate in people with End-Stage Renal Disease and Osteoporosis, run by National Taiwan University Hospital.
Trial summary
Alendronate is a safe and effective drug for treating osteoporosis in post-menopausal women. However, its safety and efficacy in increasing bone mineral density in chronic peritoneal dialysis (PD) patients have not been investigated. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- End-Stage Renal Disease, Osteoporosis
- What is being tested?
- alendronate
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Oct 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have received maintenance PD for more than 3 months at National Taiwan University Hospital,
- Have high CPP level (≧50), and
- Have chest X-ray proven aortic calcification or coronary artery calcification proven before.
Who cannot join
- Patients are excluded if they have any one of the following conditions:
- Had been hospitalized in recent 3 months due to severe comorbid diseases,
- Are hypersensitive to alendronate or any of its components,
- Have esophageal diseases
- Are not able to stand or sit upright for 30 minutes,
- Have refractory hypocalcemia, or
- Patients who are pregnant.
About this study
Official title: Can Alendronate Suppress Aortic and Coronary Artery Calcification and Improve Bone Mineral Density in Chronic Peritoneal Dialysis Patients?
Alendronate is a safe and effective drug for treating osteoporosis in post-menopausal women. However, its safety and efficacy in increasing bone mineral density in chronic peritoneal dialysis (PD) patients have not been investigated. Etidronate, another bisphosphonate, can suppress the extent of coronary artery calcification in chronic hemodialysis patients. The hypothesis of this study is that alendronate can increase bone mineral density and suppress aortic and coronary artery calcification in chronic peritoneal dialysis patients.
Read the detailed description
Study Design
The study is a prospective, randomized cross-over study. Fifty patients will be included. All participants are randomly allocated to either group 1 or group 2. Each group consists of 25 patients. Group 1 patients receive alendronate 70 mg once weekly in the first 24 weeks of the study, while group 2 patients receive the same dose of drug every week in the second 24 weeks. The extent of coronary artery and aortic calcification is evaluated by using multidetector spiral computed tomography, whereas bone mineral density is measured by dual-energy X-ray absorptiometry. Both examinations are performed at week 0, 24 and 48 for each participant. Serum level of calcium should be kept within normal limits and serum level of phosphorus should be kept below 6 mg/dl.
Administration of Alendronate
One tablet of alendronate (70 mg per tablet) should be swallowed by each patient once every week with water at least 30 minutes before breakfast, beverage or medication of the day during the treatment period. Patients must not lie down for at least 30 minutes after taking the drug.
Measurement of Coronary Artery and Aortic Calcification
Multidetector spiral computerized tomography (CT) of the chest is performed at week 0, 24 and 48 for each participant to measure the extent of coronary and aortic calcification.
Measurement of Bone Density
Dual energy X-ray absorptiometry is performed at week 0, 24 and 48 for each participant to measure the density of bone.
Demographic and Clinical Characteristics of Patients
Patients characteristics such as age and sex are documented. Clinical parameters including body height, body weight, duration of dialysis, calcium concentration of dialysate, and medication under use are recorded. Blood pressure is measured at each clinical visit for 3 times after the patient has sit for at least 15 minutes.
Collection of Laboratory Data
Fasting serum levels of albumin, phosphorus, calcium, alkaline phosphatase (ALP), intact parathyroid hormone (iPTH) and hemoglobin level of each patient are checked at study entry and once every month. Fasting serum levels of triglyceride, total cholesterol, high-density lipoprotein cholesterol (HDL-chol), low-density lipoprotein cholesterol (LDL-chol), and hypersensitive C-reactive protein (CRP) of each patient are checked at study entry and once every 3 months.
Record of Adverse Effects of Alendronate
Any adverse effect of alendronate is recorded every month at clinic visit.
Compliance of Patients
Compliance of the patients is monitored using telephone calls once every week during the treatment period with alendronate.
- Conditions
- End-Stage Renal Disease, Osteoporosis
- Being tested
- alendronate
- Keywords
- peritoneal dialysis, artery calcification, bone mineral density
- Medical subject headings
- Kidney Failure, Chronic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alendronateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
extent of aortic and coronary artery calcification with and without the use of alendronate
bone mineral density with and without the use of alendronate
Secondary outcomes (1)
serum levels of calcium, phosphorus and parathyroid hormone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2005 (estimated)
- Study startAug 2005
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Tze-Wah Kao, Master, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261625
- Sponsor's protocol ID
- 940706
- Status last verified
- Dec 2008
- First submitted
- 1 Dec 2005
- Last updated
- 5 Jan 2009
- Results posted
- No
Publications
Hara T, Hijikata Y, Matsubara Y, Watanabe N. Pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3-5D. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013424. doi: 10.1002/14651858.CD013424.pub2.
PubMed 34231877
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Alendronate Suppress Aortic and Coronary Artery Calcification and Improve Bone Mineral Density in Chronic Peritoneal Dialysis Patients?
- ClinicalTrials.gov ID
- NCT00261625
- Acronym / sponsor ID
- 940706
- Conditions
- End-Stage Renal Disease, Osteoporosis
- Keywords
- peritoneal dialysis, artery calcification, bone mineral density
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 5 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alendronate is a safe and effective drug for treating osteoporosis in post-menopausal women. However, its safety and efficacy in increasing bone mineral density in chronic peritoneal dialysis (PD) patients have not been investigated. Etidronate, another bisphosphonate, can suppress the extent of coronary artery calcification in chronic hemodialysis patients. The hypothesis of this study is that alendronate can increase bone mineral density and suppress aortic and coronary artery calcification in chronic peritoneal dialysis patients.
Detailed description
Study Design
The study is a prospective, randomized cross-over study. Fifty patients will be included. All participants are randomly allocated to either group 1 or group 2. Each group consists of 25 patients. Group 1 patients receive alendronate 70 mg once weekly in the first 24 weeks of the study, while group 2 patients receive the same dose of drug every week in the second 24 weeks. The extent of coronary artery and aortic calcification is evaluated by using multidetector spiral computed tomography, whereas bone mineral density is measured by dual-energy X-ray absorptiometry. Both examinations are performed at week 0, 24 and 48 for each participant. Serum level of calcium should be kept within normal limits and serum level of phosphorus should be kept below 6 mg/dl.
Administration of Alendronate
One tablet of alendronate (70 mg per tablet) should be swallowed by each patient once every week with water at least 30 minutes before breakfast, beverage or medication of the day during the treatment period. Patients must not lie down for at least 30 minutes after taking the drug.
Measurement of Coronary Artery and Aortic Calcification
Multidetector spiral computerized tomography (CT) of the chest is performed at week 0, 24 and 48 for each participant to measure the extent of coronary and aortic calcification.
Measurement of Bone Density
Dual energy X-ray absorptiometry is performed at week 0, 24 and 48 for each participant to measure the density of bone.
Demographic and Clinical Characteristics of Patients
Patients characteristics such as age and sex are documented. Clinical parameters including body height, body weight, duration of dialysis, calcium concentration of dialysate, and medication under use are recorded. Blood pressure is measured at each clinical visit for 3 times after the patient has sit for at least 15 minutes.
Collection of Laboratory Data
Fasting serum levels of albumin, phosphorus, calcium, alkaline phosphatase (ALP), intact parathyroid hormone (iPTH) and hemoglobin level of each patient are checked at study entry and once every month. Fasting serum levels of triglyceride, total cholesterol, high-density lipoprotein cholesterol (HDL-chol), low-density lipoprotein cholesterol (LDL-chol), and hypersensitive C-reactive protein (CRP) of each patient are checked at study entry and once every 3 months.
Record of Adverse Effects of Alendronate
Any adverse effect of alendronate is recorded every month at clinic visit.
Compliance of Patients
Compliance of the patients is monitored using telephone calls once every week during the treatment period with alendronate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have received maintenance PD for more than 3 months at National Taiwan University Hospital,
- Have high CPP level (≧50), and
- Have chest X-ray proven aortic calcification or coronary artery calcification proven before.
Key exclusion criteria (7 listed)
- Had been hospitalized in recent 3 months due to severe comorbid diseases,
- Are hypersensitive to alendronate or any of its components,
- Have esophageal diseases
- Are not able to stand or sit upright for 30 minutes,
- Have refractory hypocalcemia, or
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 |
|---|---|---|
| alendronate | Drug | – |
Primary outcome
extent of aortic and coronary artery calcification with and without the use of alendronate
bone mineral density with and without the use of alendronate
1 secondary outcome
serum levels of calcium, phosphorus and parathyroid hormone
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2009.
- Derived from this study: PubMed 34231877Hara T, Hijikata Y, Matsubara Y, Watanabe N. Pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3-5D. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013424. doi: 10.1002/14651858.CD013424.pub2.
Related trials for End-Stage Renal Disease
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
Active, not recruitingObservational study
Acetoacetate and Acetate Metabolism in Patients With Chronic Kidney Failure.(RENO-TEP)
Kidney Failure, Chronic
Active, not recruitingObservational study
Central Blood Pressure and Pulse Wave Velocity in Kidney Transplant Recipients
End Stage Renal Disease
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
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.
Tze-Wah Kao, Master principal investigator
National Taiwan University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing alendronate in people with End-Stage Renal Disease and Osteoporosis, run by National Taiwan University Hospital.
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 3 inclusion and 7 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 5 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
extent of aortic and coronary artery calcification with and without the use of alendronate. The study lists 2 primary outcomes in all. 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 NCT00261625, which also lists 1 linked publication.
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 5 Jan 2009.