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New treatment option for Adynamic Bone Disease
Official title Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease
ClinicalTrials.gov ID: NCT04522622
What this study is testing
What is Teriparatide?
Teriparatide is an investigational medicine, being studied as a potential treatment for adynamic bone disease.
Also referred to as Terrosa.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- 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...
- Patients with expected adynamic bone disorder, based on BSAP≤21 µg/l or biopsy-verified low bone turnover
You likely can't join if
- 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
See the full eligibility 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...
- Patients with expected adynamic bone disorder, based on BSAP≤21 µg/l or biopsy-verified low bone turnover
- 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...
- 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...
- For those participating in pulse wave measurements: 1) Atrial fibrillation, 2) Aorta stenosis
The study team makes the final eligibility decision.
Where it's taking place
- Aalborg, Denmark
- Gentofte Municipality, Denmark
- Herlev, Denmark
- Odense, Denmark
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, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalborg, Denmark; Gentofte Municipality, Denmark; Herlev, Denmark; Odense, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.