| CTRI Number |
CTRI/2022/03/040787 [Registered on: 03/03/2022] Trial Registered Prospectively |
| Last Modified On: |
22/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of parathyroidectomy and a drug called cinacalcet on bone biopsy indices |
|
Scientific Title of Study
|
Bone Indices before
and after parathyroidectomy or cinacalcet therapy in patients with renal
hyperparathyroidism: A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSanjay kumar Bhadada |
| Designation |
Professor & HOD Department of Endocrinology |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Dr.Sanjay Kumar Bhadada
Department of Endocrinology, Diabetes and Metabolism,
Room no 8, Nehru Extension Block
Post Graduate Institute of Medical Education and Research,
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9876602448 |
| Fax |
|
| Email |
bhadadask@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSanjay kumar Bhadada |
| Designation |
Professor & HOD Department of Endocrinology |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Dr.Sanjay Kumar Bhadada
Department of Endocrinology, Diabetes and Metabolism,
Room no 8, Nehru Extension Block
Post Graduate Institute of Medical Education and Research,
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9876602448 |
| Fax |
|
| Email |
bhadadask@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAnirudh J Shetty |
| Designation |
Senior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Dr.Anirudh.J.Shetty
I BLOCK 129 ,MDH,Post Graduate Institute of Medical Education and Research, Chandigarh
India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
07022157932 |
| Fax |
|
| Email |
anirudh004@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
Dr.Sanjay Kumar Bhadada Department of Endocrinology, Diabetes and Metabolism, Room no 8, Nehru Extension Block Post Graduate Institute of Medical Education and Research, Chandigarh 160012
Chandigarh
CHANDIGARH
160012
India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSanjay Kumar Bhadada |
Post Graduate Institute of Medical Education and Research |
Department of Endocrinology, Diabetes and Metabolism
Chandigarh
CHANDIGARH |
9876602448
bhadadask@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cinacalcet |
Dose - 30mg-180 mg.
Frequency - once daily to twice daily based on iPTH response
Route of Administration - oral
Duration - 1 year
|
| Intervention |
Parathyroidectomy |
Bone biopsy will be performed intraoperatively during curative
parathyroidectomy and also 3 to 12 months after the surgery. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Refractory sHPT defined as following: 1) Serum iPTH level greater than 800 pg/mL on two or more occasions after optimal drug therapy and/or 2)Radioisotope scan or
Ultrasound imaging shows parathyroid diffuse or nodular hyperplasia or Tertiary
Hyperparathyroidism
One serum calcium determination obtained from the central laboratory must be greater than
8.4 mg/dL
One Bone Alkaline Phosphatase (BALP) determination obtained from the central
laboratory must be greater than 20.9 ng/mL.
ESRD patients on maintainence haemodialysis |
|
| ExclusionCriteria |
| Details |
- Any chronic disease that may affect bone health significantly(eg :Cushings
disease,Addisons disease ,Severe liver disease like biliary cirrhosis)
- Pregnancy or lactation(post menopausal females)
- Had a parathyroidectomy in the 3 months, before the date of informed consent
- Ever received therapy with cinacalcet in cinacalcet arm
- Prior use of Bisphosphonates in last 5 years or Denosumab in last 1 year
- History of steroid intake(Prednisolone 5mg or equivalent for greater than 3 months in last 1
year) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the change in Bone Formation Rate(BFR) from baseline to end of the study.
Change From Baseline to End of Study in Osteoclast Perimeter (Osteoclast Perimeter/Eroded
Perimeter) |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in CT -CAC score from baseline to the end of the study |
1 year |
To compare the change in bone micro architecture & BMD from before and after
parathyroidectomy/cinacalcet therapy.
|
1 year |
To compare the various biochemical and bone turnover markers from before and
after parathyroidectomy/cinacalcet therapy. |
1 year |
| Change From Baseline to End of Study in Fibrosis Area/Tissue Area |
1 year |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
07/03/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a randomised ,parallel group,single centre trial done to assess the effect of parathyroidectomy & cinacalcet therapy on bone histology changes,biochemical and densitometric parameters in dialysis patients with refractory secondary hyperparathyroidism or tertiary hyperparathyroidism.The primary outcome measure will be change from baseline to end of Study in Bone Formation Rate (BFR) and change from Baseline to end of study in Osteoclast Perimeter (Osteoclast Perimeter/Eroded Perimeter) on bone biopsy.The secondary outcomes will be to compare the various biochemical and bone turnover markers , change in bone micro architecture,Fibrosis Area/Tissue Area and CT -CAC score before and after parathyroidectomy/cinacalcet therapy. |