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Treatment of adynamic bone disorder with parathyroid hormone in patients with chronic kidney disease
EU CTIS ID: 2023-506853-39-00
What this study is testing
The primary objective of this trial is to evaluate whether 18 months of treatment with teriparatide is more efficient than no treatment on improvement of bone metabolism in patients with chronic kidney disease and adynamic bone disorder.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥18 years
- CKD stage 4-5D (eGFR ≤29 ml/min) according to KDIGO (Kidney Disease Improving Global Outcome) definition
- DEXA 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 vertebrae (for patients with active oral prednisolone treatment ≥ 5 mg/day for minimum 3 months the T-score or Z-score limit is <-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 (11) or biopsy-verified low bone turnover
You likely can't join if
- Hypercalcemia defined as sustained ionized calcium >1.35 mmol/l
- Drug or alcohol abuse
- Previous fracture within the last 6 months (Patients may be rescreened after the 6 months)
- 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, 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
See the full eligibility criteria
- Age ≥18 years
- CKD stage 4-5D (eGFR ≤29 ml/min) according to KDIGO (Kidney Disease Improving Global Outcome) definition
- DEXA 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 vertebrae (for patients with active oral prednisolone treatment ≥ 5 mg/day for minimum 3 months the T-score or Z-score limit is <-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 (11) or biopsy-verified low bone turnover
- Hypercalcemia defined as sustained ionized calcium >1.35 mmol/l
- Drug or alcohol abuse
- Previous fracture within the last 6 months (Patients may be rescreened after the 6 months)
- 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, 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
- 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)
- Patients who have undergone a kidney transplantation within 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
- 25 hydroxyvitamin D2 and D3 <50 nmol/l (Patients may be rescreened after correction)
- Inability to administer teriparatide
- Reduced liver function (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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.