Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Treatment with digoxin * Pag