Using parathyroid hormone to treat bone disorder in kidney disease patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a 1:1 randomized controlled trial designed to evaluate the safety and efficacy of recombinant human parathyroid hormone (PTH) in treating adynamic bone disorder in patients with chronic kidney disease (CKD). The intervention lasts for 18 months, followed by a 12-month follow-up period. The study aims to determine if PTH treatment can enhance bone turnover and mineral density, thereby reducing fracture risk and improving cardiovascular health in CKD patients. Various assessments, including DXA scans and cardiac tests, will be conducted to monitor outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Herlev and Gentofte Hospital, Herlev Hospital
  Herlev, Denmark Recruiting
• Aalborg University Hospital
  Aalborg, Denmark Not yet recruiting
• Steno Diabetes Center Copenhagen
  Gentofte Municipality, Denmark Not yet recruiting
• Odense University Hospital
  Odense, Denmark Not yet recruiting

Study contacts

• Principal investigator: Ditte Hansen, MD, PhD — Department of Nephrology, Herlev and Gentofte Hospital
• Study coordinator: Sabina C Hauge, MD
• Email: sabina.chaudhary.hauge@regionh.dk
• Phone: +4528965887

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.