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
Parallel
Teriparatide
Drug20 micrograms
DXA,VFA, X-ray, HR-pQCT, 18-F NAF PET/CT
Diagnostic testAll participants undergo DXA and VFA or X-ray scans 3 times during the study. Some participants (those connected to Herlev) are offered 18F NAF PET/CT scans at baseline and after 12 months and some participants (those connected to Odense University Hospital and Aalborg University Hospital) are offered HR-pQCT scans at baseline and after 12 months. The 18F-NAF PET/CT and HR-pQCT are optional, so it is not a must to have these procedures done to participate in the study.
Bone biopsy
Procedure/SurgeryAll participants are invited to undergo a bone biopsy after 12 months, but it is not a must to have the procedure done to participate in the study.
Cardiac tests
Diagnostic testAll participants are invited to undergo 24-hour blood pressure measurements and pulse wave measurements at baseline and after 18 months, but it is not a must to have these procedures done to participate in the study.
Blood and urine samples and physical examination
Other interventionAll participants must undergo a physical examination and deliver blood and urine samples in order to participate in the study.
Changes in bone specific alkaline phosphatase (BSAP)
The difference between treated and controls in changes from baseline to 18 months in bone specific alkaline phosphatase
Number of patients who no longer has adynamic bone disorder based on a BSAP >21 µg/l
Changes between baseline and 18 months as well as differences between treated and controls.
BMD at the lumbar spine, antebrachium, femoral neck and total hip
Changes between baseline and 18 months as well as differences between treated and controls
Incidence of fragility fractures and vertebral fractures assessed using x-ray of columna or vertebral fracture assessment (VFA)
Changes between baseline and 18 months as well as differences between treated and controls
Bone microarchitecture assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT)
Changes between baseline and 12 months as well as differences between treated and controls. The HR-pQCT scan is a voluntary procedure.
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Ditte Hansen
Lead sponsor
Herlev Hospital
Sponsor institution
Odense University Hospital
Collaborator
Steno Diabetes Center Copenhagen
Collaborator
Rigshospitalet, Denmark
Collaborator
Aalborg University Hospital
Collaborator
