adynamic bone disease osteitis fibrosa chronic kidney disease mineral bone disorders fractures low bone mineral density hemodialysis Bone histomorphometry Bone turnover Bone mineral density Hemodialysis adynamic bone disease osteitis fibrosa
Conditions
Interventions
Teriparatide (RECOMBINANT HUMAN PARATHYROID HORMONE,
MEGA-
PTH®)m20 micrograms subcutaneous once daily
Plus
Standard treatment for ABD*
1.Withdraw all prior calcium-
based phosphate binder and switch to Lanthanum (FOSRENOL®) with titration to maintain corrected serum calcium 8.0 to 10 mg/dL,
and serum phosphate level between 3.5 and 5.5 mg/dL.
2.Withdraw any calcitriol or vitamin D analogs,
if previously taken
3.Continue previous dose of inactive vitamin D (ergocalciferol or cholecalciferol)
4.Adjust dialysate calcium concentration to 2.5 or 3.0 mEq/L as appropriate (without symptomati
cramps,
or intradialytic hypotension in absence of other cause)
5.Formal nutritional education for low phosphate diet,Standard treatment for ABD*
1.Withdraw all prior calcium-
or intradialytic hypotension in absence of other cause)
5.Formal nutritional education for low phosphate diet,Cinacalcet hydrochloride (REGPARA®) orally using dose of 25-
100 mg/day by titration protocol 25 mg every 3 week until maximum dose or serum PTH 150-
585 pg/mL
plus low dose Calcitriol (CALCIT-
SG®) orally as 0.25 micrograms 3 times/week ,Calcitriol (CALCIT-
SG®) orally using dose 0.75 – 3.00 micrograms per week adjust in order to main
Experimental Drug,Active Comparator Other,Experimental Drug,Active Comparator Drug
[A] Teriparatide plus standard treatment (low bone turnover) ,[A] Standard treatment (low bone turnover),[B] Cinacalcet hydrochloride plus low dose calcitriol (high bone turnover),[B] Calcitriol (hig
Sponsors
Faculty of Medicine, Chulalongkorn University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
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
Exclusion criteria: 1.Active malignancy or history of primary or secondary neoplasm of bone 2.Bleeding tendency defined by: platelet counts 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Bone alkaline phosphatase 28 and 52 weeks immunoassay,Tartrate-resistance acid phosphatase 5b (TRAP-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-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, 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 | — |
Contacts
Public ContactJeerath Phannajit
Research Unit for Metabolic Bone Disease in CKD patients, Division of Nephrology, Department of Medi
Outcome results
None listed