Condition category
Urological and Genital Diseases
Date applied
02/10/2018
Date assigned
01/11/2018
Last edited
01/11/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

https://www.vghks.gov.tw/

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

Publication citations

Additional files

Editorial Notes