Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease

Prior treatment

• Previous fracture withon the last 6 months \*Patients may be rescreened after the 6 months
• Previous calciphylaxis
• Treatment with digoxin
• Antiresorptive or bone anabolic medication during the last 24 months (for bisphosphonates it is only during the last 12 months)
• Previous external beam or implant radiation therapy to the skeleton
• Patients who have undergone a kidney transplantation within the last 12 months
• Pregnancy, lactation or fertile women (post-menopausal females are not considered fertile) not using safe anticonception (the following contraceptive methods are considered appropriate: Intrauterine device (IUD) or hormonal anticontraceptive (oral contraceptives, implant, transdermal patches, vaginal ring or depot injection)).
• Drug or alcohol abuse
• For those participating in the bone biopsy procedure: 1) Hypersensitivity to any of the tetracyclines or to any of the excipients or content, 2) Treatment with anticoagulants (vitamin K antagonists, Non-vitamin K Antagonist Oral Anticoagulants (NOAC), unfractionated or low-molecular heparin or antiplatelet agents that, due to clinical indication can't be paused, 3) Disturbances in thrombosis and/or haemostasis

Other illness

• Paget's disease or other metabolic bone disorders
• Former or present malignant disease (except skin basal or planocellular carcinoma)
• Hypersensitivity to the active substance in teriparatide or to any of the excipients or content
• Medical conditions or treatments that may interfere with assessments of the outcomes of the trial

Lab values

• Hypercalcemia defined as sustained ionized calcium \>1.35 mmol/l
• Reduced liver function \*Alanine Aminotransferase (ALAT) \>3x upper limit of normal or bilirubin \> 2x upper limit of normal

Other

• Thyroid disturbances not adequately treated based on the opinion by the clinician \*Patients may be rescreened after treatment optimization
• 25 hydroxyvitamin D2 and D3 \<50 nmol/l \*Patients may be rescreened after correction
• Inability to administer teriparatide
• Inability to provide informed consent
• Unable to participate in a clinical study based on the judgement by the local investigator
• For those participating in pulse wave measurements: 1) Atrial fibrillation, 2) Aorta stenosis

• 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