This study is a 1:1 randomized controlled trial with an intervention for 18 months and a follow up period of 12 months. The purpose of the study is to assess the safety and efficacy of recombinant human parathyroid hormone for treatment of adynamic bone disorder in patients with chronic kidney disease.
Age ≥18 years
CKD stage 4-5D (eGFR ≤29 ml/min) according to Kidney Disease Improving Global Outcomes(KDIGO) definition
DXA scan with a T-score at the total hip, femoral neck or lumbar spine (L1-4) ≤-2 (or Z-score ≤-2) in a minimum of 2 vertebraes (for patients with active oral prednisolone treatment ≥ 5 mg/day for minimum 3 months the T-score or Z-score limit i < -1) and/or former fragility fracture (vertebral, hip, for- or upper arm, ankle) assessed with VFA or x-ray of the columna
Patients with expected adynamic bone disorder, based on BSAP≤21 µg/l or biopsy-verified low bone turnover
Hypercalcemia defined as sustained ionized calcium >1.35 mmol/l
Previous fracture withon the last 6 months *Patients may be rescreened after the 6 months
Previous calciphylaxis
Thyroid disturbances not adequately treated based on the opinion by the clinician *Patients may be rescreened after treatment optimization
Ditte Hansen
Lead sponsor
Herlev Hospital
Sponsor institution
Odense University Hospital
Collaborator
Steno Diabetes Center Copenhagen
Collaborator
Rigshospitalet, Denmark
Collaborator
Aalborg University Hospital
Collaborator