Status:
RECRUITING
Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease
Lead Sponsor:
Ditte Hansen
Collaborating Sponsors:
Odense University Hospital
Steno Diabetes Center Copenhagen
Conditions:
Adynamic Bone Disease
Chronic Kidney Diseases
Eligibility:
All Genders
18-120 years
Phase:
PHASE4
Brief 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 hum...
Detailed Description
This study is a 1:1 randomized controlled trial with an intervention for 18 months and a follow up period of 12 months. The study will explore if treatment with recombinant human parathyroid hormone ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04522622
Start Date
December 15 2021
End Date
September 1 2027
Last Update
April 23 2024
Active Locations (4)
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1
Aalborg University Hospital
Aalborg, Denmark, 9000
2
Steno Diabetes Center Copenhagen
Gentofte Municipality, Denmark, 2820
3
Herlev and Gentofte Hospital, Herlev Hospital
Herlev, Denmark, 2730
4
Odense University Hospital
Odense, Denmark, 5000