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Clinical Trials in Denmark / NCT04522622
Recruiting Phase 4

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

NCT04522622 · tracked via the Priya Life Science Denmark tracker
Sponsor
Ditte Hansen
Phase
Phase 4
Started
2021-12-15
Last updated
2024-04-23

Condition(s) studied

Adynamic Bone DiseaseChronic Kidney DiseasesCardiac DiseaseChronic Kidney Disease-Mineral and Bone Disorder

Investigational drug(s) / intervention(s)

Teriparatide →DXA,VFA, X-ray, HR-pQCT, 18-F NAF PET/CTBone biopsyCardiac testsBlood and urine samples and physical examination

Teriparatide: 20 micrograms

DXA,VFA, X-ray, HR-pQCT, 18-F NAF PET/CT: All 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: All 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: All 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: All participants must undergo a physical examination and deliver blood and urine samples in order to participate in the study.

Study 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

Sex
ALL
Min age
18 Years
Max age
120 Years
Healthy volunteers
No
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 * Paget's disease or other metabolic bone disorders * Antiresorptive or bone anabolic medication during the last 24 months (for bisphosphonates it is only during the last 12 months) * Former or present malignant disease (except skin basal or planocellular carcinoma) * Previous external beam or implant radiation therapy to the skeleton * Patients who have undergone a kidney transplantation within the last 12 months * 25 hydroxyvitamin D2 and D3 \<50 nmol/l \*Patients may be rescreened after correction * 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 or alcohol abuse * 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 or antiplatelet agents that, due to clinical indication can't be paused, 3) Disturbances in thrombosis and/or haemostasis * For those participating in pulse wave measurements: 1) Atrial fibrillation, 2) Aorta stenosis

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Aalborg University Hospital Aalborg Denmark Not Yet Recruiting
Steno Diabetes Center Copenhagen Gentofte Municipality Denmark Not Yet Recruiting
Herlev and Gentofte Hospital, Herlev Hospital Herlev Denmark Recruiting
Odense University Hospital Odense Denmark Not Yet Recruiting

More Ditte Hansen trials in Denmark

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04522622 on ClinicalTrials.gov ↗ ← All trials in Denmark