Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease (NCT04522622) | Clinical Trial Compass
RecruitingPhase 4
Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease
Denmark48 participantsStarted 2021-12-15
Plain-language 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.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 correct…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in bone specific alkaline phosphatase (BSAP)