Precision treatment for Renal Osteodystrophy Guided by Bone Histomorphometry in Hemodialysis Patient with Low Bone Mineral Density

Phase 3

Recruiting

• Conditions: adynamic bone diseaseosteitis fibrosachronic kidney disease mineral bone disordersfractureslow bone mineral density hemodialysis; Bone histomorphometry; Bone turnover; Bone mineral density; Hemodialysis; adynamic bone disease; osteitis fibrosa

• Registration Number: TCTR20190725001
• Lead Sponsor: Faculty of Medicine, Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-25
• Study Completion: 2020-08-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1.Adult (Age ≥18-year-old)
2.End-stage renal disease on chronic hemodialysis ≥ 3 months
3.BMD T-score at the total hip, femoral neck, lumbar spine or distal forearm ≤ -2.5 or ≤ -1.0 with a presence of previous fragility fracture
4.Serum intact parathyroid hormone (iPTH) level between 150 to 800 picogram per milliliter

5.Tetracycline double-labelled trans-iliac bone biopsy with Histomorphometry
shown - low bone turnover disease (ABD) for Arm A and - high bone turnover disease for Arm B

Exclusion Criteria

1.Active malignancy or history of primary or secondary neoplasm of bone
2.Bleeding tendency defined by: platelet counts < 150,000 per microliters, prolonged prothrombin time (PT) > 3 sec from normal control or activated partial thromboplastin time (APTT) > 2 times of normal control or currently taking anticoagulation or antiplatelets.
3.Chronic heart failure, arrhythmias or chronic lung disease patient who unable to do prone position while biopsy procedure.
4.History of allergy or severe adverse reaction to tetracycline and meperidine
5.Pregnancy or breastfeeding
6.Presence of connective tissue or bone disease affected in bone fragility e.g. rheumatoid arthritis, osteomalacia, chronic steroid use (prednisolone > 20mg/d for> 90 days)
7.Presence of multiple prosthesis which unable to measure at least 1 site of DXA-BMD
8.Current or previous use of osteoporosis medications.
9.Presence of other cause of bone abnormality e.g. Aluminum toxicity, mixed renal osteodystrophy according to bone histology.
10.History of allergy or severe adverse reaction to teriparatide and lanthanum (for arm A) and cinacalcet and calcitriol (for arm B)
11.Corrected QT interval frome 12-leads EKG more than 500 milisecconds (for arm B)
12.Anticipated living donor kidney transplant within study period

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone mineral density change 52 weeks Dual energy X-ray absorptiometry,different mean of percent change of BMD at total hip, femoral neck, lumbar spine and distal forearm 28 and 52 weeks Dual energy X-ray absorptiometry

Secondary Outcome Measures

Name	Time	Method
Bone alkaline phosphatase 28 and 52 weeks immunoassay,Tartrate&#45;resistance acid phosphatase 5b (TRAP&#45;5b) 28 and 52 weeks immunoassay,Bone formation rate 52 weeks Bone histomorphometry from transiliac bone biopsy with double tetracycline labelling,Adverse event related to bone biopsy procedure anytime during study period Adverse reaction to tetracycline/ii.Severe post&#45;operative pain required admission / Bleeding compli,Symptomatic and asymptomatic hypercalcemia anytime during study period corrected serum Ca persistently > 10.6 mg/dl,Symptomatic and asymptomatic hypocalcemia anytime during study period corrected serum calcium was <7.5 mg/dl ,Nausea&#44; vomiting and diarrhea (required and not required to hospitalization) anytime during study period ้history taking,Intradialytic hypotension which required intervention or early termination of dialysis session. anytime during study period history taking