Plain English Summary
Background and study aims
In a previous study of the drug denosumab for the treatment of severe hyperparathyroidism (too much parathyroid hormone) in patients with low bone mass undergoing dialysis, patients could benefit from bone mass gain and bone pain relief. In dialysis patients, this drug is relatively safe because each dialysis session delivers calcium into the circulation. However, reportedly, calcium and active vitamin D given to prevent hypocalcemia (low blood calcium) can lead to ectopic calcification (calcium build up). Using appropriate calcium dialysate (dialysis fluid) to make total body calcium as balanced as possible, denosumab could cause bone mass gain and reduce soft tissue and vessel calcification. This study aims to recruit patients with end stage renal (kidney) disease with hyperparathyroidism and low bone mass. The goal is to find whether denosumab could slow coronary artery calcification in patients with hyperparathyroidism undergoing regular dialysis.
Who can participate?
Patients aged 18 and over with end stage renal disease with hyperparathyroidism and low bone mass
What does the study involve?
Participants are allocated to one of two groups by their wishes, to receive either denosumab or not. All participants attend for a CT scan of the heart to measure blood vessel calcification. Participants attend for a review at 6 months.
What are the possible benefits and risks of participating?
The participants could benefit from free CT scans to monitor their heart. The participants who receive denosumab are closely monitored during the dialysis process. However, there could still be a risk of hypocalcemia.
Where is the study run from?
Kaohsiung Veterans General Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
September 2013 to August 2018
Who is funding the study?
Kaohsiung Veterans General Hospital (Taiwan)
Who is the main contact?
Dr Chien-Liang Chen
cclchen@seed.net.tw
Trial website
Contact information
Type
Scientific
Primary contact
Dr Chien-Liang Chen
ORCID ID
http://orcid.org/0000-0002-9508-8396
Contact details
386-Ta-Chung First section road
Kaohsiung City
81410
Taiwan
+886 (0)7 3422121 ext 2109
cclchen@seed.net.tw
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
KSC104-051
Study information
Scientific title
Changes in cardiovascular calcification after denosumab in dialysis patients with secondary hyperparathyroidism and low bone mass
Acronym
Study hypothesis
The effect of denosumab on vascular calcification in patients with chronic renal failure patients with low bone mass has been a subject of interest. The purpose of this investigation is to determine changes in vascular calcification after the administration of denosumab by using fast-gated helical computed axial tomographic imaging to measure coronary and abdomen aorta calcification.
Ethics approval
Kaohsiung V.G.H. Institutional Review Board, 17/09/2013, ref: VGHKS-CT18-CT8-19
Study design
Non-randomised study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format
Condition
Patients with ESRD undergoing dialysis with severe hyperparathyroidism and low bone mass
Intervention
The effect of denosumab on vascular calcification in patients with chronic renal failure patients with low bone mass has been a subject of interest. The purpose of this investigation is to determine changes in vascular calcification after the administration of denosumab by using fast-gated helical computed axial tomographic imaging to measure coronary and abdomen aorta calcification.
Participants are allocated to one of two groups by their wishes, to receive either 60 mg denosumab (denosumab group) or conventional treatment (control group). All participants have a screening visit combined with a baseline visit, and if happy to participate and they will attend for a CT scan of the heart at baseline and at the 6-month follow-up examination to determine bone mineral density and blood vessel calcification.
Intervention type
Drug
Phase
Phase I
Drug names
Denosumab
Primary outcome measure
Coronary and abdomen aorta calcification measured using fast-gated helical computed axial tomographic imaging at baseline and 6 months
Secondary outcome measures
Osteopenia measured using dual-energy X-ray absorptiometry (DEXA) at baseline and 6 months
Overall trial start date
17/09/2013
Overall trial end date
08/08/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
In accordance with the regulatory guidelines, the patients were enrolled in the peritoneal dialysis or hemodialysis patient groups. Key inclusion criteria were age >18 years, normal laboratory tests at screening and baseline, and clinically acceptable physical examination and electrocardiograph results at screening. The study protocol was therefore amended to include requirements for daily supplementation of calcium and calcitriol according to standard dialysis guideline in all subjects with ESRD with low bone mass and a history of iPTH>800 pg/mL. All of the patients had been receiving renal replacement therapy, had various degrees of osteopenia with bone mineral densities, which were measured by dual-energy X-ray absorptiometry (DEXA); furthermore, all patients had a forearm, femoral neck or lumbar spine T score lower than -2.5 SD, indicative of low bone mass.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
21
Participant exclusion criteria
Key exclusion criteria were known sensitivity to any study treatment, unstable medical condition, history of malignancy, active infection, pregnancy, lactation, nursing, parathyroidectomy with parathyromatosis, drug abuse at screening, and aluminum levels >20 µg/L
Recruitment start date
08/10/2013
Recruitment end date
16/09/2016
Locations
Countries of recruitment
Taiwan
Trial participating centre
Kaohsiung Veterans General Hospital
386 Ta-chung first section road
Kaohsiung City
81410
Taiwan
Sponsor information
Organisation
Kaohsiung Veterans General Hospital
Sponsor details
386 Ta-chung First Road
Kaohsiung City
81410
Taiwan
+886 (0)7 3422121 ext 2109 or +886 (0)975581961
cclchen@seed.net.tw
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Kaohsiung Veterans General Hospital, VGHKS 104-051 and VGHKS105-080
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Submission to journal
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Chien-Liang Chen (cclchen1@vghks.gov.tw).
Intention to publish date
31/12/2018
Participant level data
Available on request
Basic results (scientific)
Publication list