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Trial · Interventional

RecruitingPhase 4Registry data

Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease

NCTNCT04522622 (opens ClinicalTrials.gov in a new tab)Other idDANDYNAMIC BONEOther id2018-003888-56Other id2018

Overview

Status
Recruiting
Phase
Phase 4
Enrollment
48 participants (estimated)
Sponsor
Ditte Hansen · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Denmark

Start
15 Dec 2021
Primary completion
1 Sept 2026 (estimated)
Completion
1 Sept 2027 (estimated)
First posted
21 Aug 2020
Last update posted
23 Apr 2024
Conditions
Adynamic Bone Disease · Chronic Kidney Diseases · Cardiac Disease · Chronic Kidney Disease-Mineral and Bone Disorder

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202420262028
  1. Ph 4

    Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease

    NCT04522622

    15 Dec 2021 to est. 1 Sept 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TeriparatideDrug
  • DXA,VFA, X-ray, HR-pQCT, 18-F NAF PET/CTDiagnostic test
  • Bone biopsyProcedure
  • Cardiac testsDiagnostic test
  • Blood and urine samples and physical examinationOther

Arms2

  • Experimental

    Teriparatide

    Patients receive teriparatide 20 micrograms once daily for 18 months

  • Other

    Controls

    Controls receive no treatment with teriparatide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Changes in bone specific alkaline phosphatase (BSAP)

    Time frame · Baseline and 18 months

    Registry description

    The difference between treated and controls in changes from baseline to 18 months in bone specific alkaline phosphatase

Secondary outcomes(20)
  1. Number of patients who no longer has adynamic bone disorder based on a BSAP >21 µg/l

    Time frame · Baseline and 18 months. It is also measured through study completion, an average of 30 months

    Registry description

    Changes between baseline and 18 months as well as differences between treated and controls.

  2. BMD at the lumbar spine, antebrachium, femoral neck and total hip

    Time frame · Baseline and 18 months. The scan is also performed at 30 months

    Registry description

    Changes between baseline and 18 months as well as differences between treated and controls

  3. Incidence of fragility fractures and vertebral fractures assessed using x-ray of columna or vertebral fracture assessment (VFA)

    Time frame · Baseline and 18 months. The scan is also performed at 30 months

    Registry description

    Changes between baseline and 18 months as well as differences between treated and controls

  4. Bone microarchitecture assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT)

    Time frame · Baseline and 12 months

    Registry description

    Changes between baseline and 12 months as well as differences between treated and controls. The HR-pQCT scan is a voluntary procedure.

  5. Volumetric BMD assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT)

    Time frame · Baseline and 12 months

    Registry description

    Changes between baseline and 12 months as well as differences between treated and controls. The HR-pQCT scan is a voluntary procedure.

  6. Bone geometry assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT)

    Time frame · Baseline and 12 months

    Registry description

    Changes between baseline and 12 months as well as differences between treated and controls. The HR-pQCT scan is a voluntary procedure.

  7. Bone strength assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT)

    Time frame · Baseline and 12 months

    Registry description

    Changes between baseline and 12 months as well as differences between treated and controls. The HR-pQCT scan is a voluntary procedure.

  8. Regional bone formation using 18F-Sodium Fluoride Positron Emission Tomography/Computed Tomography (18F-NAF PET/CT)

    Time frame · Baseline and 12 months

    Registry description

    Changes between baseline and 12 months as well as differences between treated and controls. The 18F-NAF PET/CT is a voluntary procedure.

  9. Changes in p-PTH

    Time frame · Baseline and 18 months. Some of them are also measured during follow up.

    Registry description

    Changes between baseline and 18 months as well as differences between treated and controls.

  10. Changes in p-phosphate

    Time frame · Baseline and 18 months. Some of them are also measured during follow up.

    Registry description

    Changes between baseline and 18 months as well as differences between treated and controls.

  11. Changes in p-magnesium

    Time frame · Baseline and 18 months. Some of them are also measured during follow up.

    Registry description

    Changes between baseline and 18 months as well as differences between treated and controls.

  12. Changes in calcium

    Time frame · Baseline and 18 months. Some of them are also measured during follow up.

    Registry description

    P-ionised calcium. Changes between baseline and 18 months as well as differences between treated and controls.

  13. Bone histomorphometry

    Time frame · 12 months

    Registry description

    Static and dynamic bone histomorphometry classified by the bone Turnover Mineralization Volume (TMV) classification assessed by bone biopsy. Performed after 12 months. This is a voluntary procedure.

  14. Changes in Intact Procollagen type 1 N-terminal Propeptide (P1NP)

    Time frame · Baseline and 18 months. They are also measured during follow up

    Registry description

    Changes between baseline and 18 months as well as differences between treated and controls.

  15. Changes in total P1NP

    Time frame · Baseline and 18 months. They are also measured during follow up

    Registry description

    Changes between baseline and 18 months as well as differences between treated and controls.

  16. Changes in Tartrate-Resistant Acid Phosphatase 5b (TRAP5b)

    Time frame · Baseline and 18 months. They are also measured during follow up

    Registry description

    Changes between baseline and 18 months as well as differences between treated and controls.

  17. Changes in sclerostin

    Time frame · Baseline and 18 months. They are also measured during follow up

    Registry description

    Changes between baseline and 18 months as well as differences between treated and controls.

  18. Changes in Receptor Activator of Nuclear factor Kappa-B Ligand (RANKL)

    Time frame · Baseline and 18 months. They are also measured during follow up

    Registry description

    Changes between baseline and 18 months as well as differences between treated and controls.

  19. Changes in Osteoprotegerin (OPG)

    Time frame · Baseline and 18 months. They are also measured during follow up

    Registry description

    Changes between baseline and 18 months as well as differences between treated and controls.

  20. Changes in Fibroblast Growth Factor 23 (FGF-23)

    Time frame · Baseline and 18 months. They are also measured during follow up

    Registry description

    Changes between baseline and 18 months as well as differences between treated and controls.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 120 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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