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

• Status: Recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ditte Hansen
• Collaborators: Odense University Hospital; Rigshospitalet, Denmark; Steno Diabetes Center Copenhagen; Universiteit Antwerpen
• Treatments: Fluorides; Listerine; Sodium Fluoride; Teriparatide

Criteria

Inclusion Criteria:

• Age ≥18 years

• CKD stage 4-5 not on dialysis (nonD) (eGFR ≤30 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) and/or former fragility fracture (vertebral, hip, for- or upper arm, ankle) assessed with x-ray of the columna

• Patients with expected adynamic bone disorder, based on BSAP≤21 µg/l

Exclusion Criteria:

• Hypercalcemia defined as ionized calcium >1.35 mmol/l

• Thyroid stimulating hormone (TSH) outside of normal range (0.3-4.0 x 103 int.U/l)

• Treatment with digoxin

• Paget's disease or other metabolic bone disorders

• Antiresorptive or bone anabolic medication during the last 24 months

• Cinacalcet treatment during the last 6 months

• Former or present malignant disease (except skin basal or planocellular carcinoma)

• Previous external beam or implant radiation therapy to the skeleton

• Kidney transplanted patients

• Prednisolone treatment during the last 6 months

• 25 hydroxyvitamin D2 and D3 <50 nmol/l *Patients may be rescreened after correction

• CKD 4 and PTH >19 pmol/l *PTH >2x upper limit

• CKD 5 and PTH > 27pmol/l *PTH >3x upper limit

• Inability to administer teriparatide

• Reduced liver function *Alanine Aminotransferase (ALAT) >3x upper limit of normal or bilirubin > 2x upper limit of normal

• 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)).

• Hypersensitivity to the active substance in teriparatide or to any of the excipients or content

• Inability to provide informed consent

• Medical conditions or treatments that may interfere with assessments of the outcomes of the trial

• Drug abuse, including consumption of more than 3 units of alcohol per day

• Unable to participate in a clinical study based on the judgement by the local investigator

• 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, antiplatelet agents, 3) Disturbances in thrombosis and/or haemostasis

• For those participating in pulse wave measurements: 1) Atrial fibrillation, 2) Aorta stenosis