Changes in cardiovascular calcification after denosumab in dialysis patients with secondary hyperparathyroidism and low bone mass
| ISRCTN | ISRCTN92563400 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92563400 |
| Secondary identifying numbers | KSC104-051 |
- Submission date
- 02/10/2018
- Registration date
- 01/11/2018
- Last edited
- 09/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Scientific
386-Ta-Chung First section road
Kaohsiung City
81410
Taiwan
 ORCID ID |
0000-0002-9508-8396 |
|---|---|
| Phone | +886 (0)7 3422121 ext 2109 |
| cclchen@seed.net.tw |
Study information
| Study design | Non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format |
| Scientific title | Changes in cardiovascular calcification after denosumab in dialysis patients with secondary hyperparathyroidism and low bone mass |
| Study objectives | 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(s) | Kaohsiung V.G.H. Institutional Review Board, 17/09/2013, ref: VGHKS-CT18-CT8-19 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | 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 study start date | 17/09/2013 |
| Completion date | 08/08/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 21 |
| Total final enrolment | 42 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 08/10/2013 |
| Date of final enrolment | 16/09/2016 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Kaohsiung City
81410
Taiwan
Sponsor information
Hospital/treatment centre
386 Ta-chung First Road
Kaohsiung City
81410
Taiwan
| Phone | +886 (0)7 3422121 ext 2109 or +886 (0)975581961 |
|---|---|
| cclchen@seed.net.tw | |
| Website | https://www.vghks.gov.tw/ |
"ROR" |
https://ror.org/04jedda80 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Submission to journal |
| IPD sharing plan | 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 09/08/2022 | No | No | ||
| Results article | 01/08/2020 | 09/08/2022 | Yes | No |
Additional files
Editorial Notes
09/08/2022: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
3. Uploaded protocol (not peer-reviewed) as an additional file.
