Trial · Interventional
RecruitingPhase 4Registry dataTreatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease
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
- Ph 4
Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease
NCT0452262215 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.
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)
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.
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
PepBank is a research reference. Talk to a doctor before you use any peptide.