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

Phase 4

• Conditions: Health Condition 1: N186- End stage renal diseaseHealth Condition 2: O- Medical and Surgical

• Registration Number: CTRI/2022/03/040787
• Lead Sponsor: PGIMER Chandigarh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 <br/ ><br>parathyroidectomy/cinacalcet therapy. <br/ ><br>Timepoint: 1 year;To compare the various biochemical and bone turnover markers from before and <br/ ><br>after parathyroidectomy/cinacalcet therapy.Timepoint: 1 year