Health Condition 1: N186- End stage renal disease Health Condition 2: O- Medical and Surgical
Conditions
Interventions
Intervention1: Parathyroidectomy: Bone biopsy will be performed intraoperatively during curative
parathyroidectomy and also 3 to 12 months after the surgery.
Control Intervention1: Cinacalcet: Dose -
Sponsors
PGIMER Chandigarh
Eligibility
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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)Timepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline to End of Study in Fibrosis Area/Tissue AreaTimepoint: 1 year;Change in CT -CAC score from baseline to the end of the studyTimepoint: 1 year;To compare the change in bone micro architecture & BMD from before and after parathyroidectomy/cinacalcet therapy. Timepoint: 1 year;To compare the various biochemical and bone turnover markers from before and after parathyroidectomy/cinacalcet therapy.Timepoint: 1 year | — |
Countries
India
Contacts
Public ContactDrAnirudh J Shetty
Post Graduate Institute of Medical Education and Research
Outcome results
None listed