A clinical trial to study the effects of parathyroidectomy and a drug called cinacalcet on bone biopsy indices

Phase 4

Not yet recruiting

Conditions: End stage renal disease, (2) ICD-10 Condition: O||Medical and Surgical,

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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).

Primary Outcome Measures

Name	Time	Method
To compare the change in Bone Formation Rate(BFR) from baseline to end of the study.	1 year
Change From Baseline to End of Study in Osteoclast Perimeter (Osteoclast Perimeter/Eroded	1 year
Perimeter)	1 year

Secondary Outcome Measures

Name	Time	Method
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.
To compare the various biochemical and bone turnover markers from before and	after parathyroidectomy/cinacalcet therapy.
Change From Baseline to End of Study in Fibrosis Area/Tissue Area	1 year

Locations (1): Post Graduate Institute of Medical Education and Research
🇮🇳
Chandigarh, CHANDIGARH, India
Post Graduate Institute of Medical Education and Research
🇮🇳Chandigarh, CHANDIGARH, India
DrSanjay Kumar Bhadada
Principal investigator
9876602448
bhadadask@gmail.com