Adynamic Bone DiseasePhase 4NCT04522622
Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease
A Phase 4 study testing Teriparatide, DXA,VFA, X-ray, HR-pQCT, 18-F NAF PET/CT and Bone biopsy in people with Adynamic Bone Disease and Chronic Kidney Diseases, run by Ditte Hansen at 4 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Adynamic Bone Disease, Chronic Kidney Diseases, Cardiac Disease
- What is being tested?
- Teriparatide, DXA,VFA, X-ray, HR-pQCT, 18-F NAF PET/CT and Bone biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 4 sitesDenmark
- Study dates
- 15 Dec 2021to 1 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark4 sites, 4 recruiting
- Not yet recruiting
Aalborg University Hospital
Aalborg, 9000
Charlotte Strandhave, MD, PhD, +4597665500, charlotte.strandhave@rn.dk
My HS Svensson, MD, PhD, +4597665500, my.svensson@rn.dk
- Not yet recruiting
Steno Diabetes Center Copenhagen
Gentofte Municipality, 2820
Frederik Persson, MD, DMSc, +4539680800, frederik.persson@regionh.dk
Frederik Persson, MD, DMSc.
- Recruiting
Herlev and Gentofte Hospital, Herlev Hospital
Herlev, 2730
Sabina C Hauge, MD, +4528965887, sabina.chaudhary.hauge@regionh.dk
Ditte Hansen, MD, PhD, +4538682056, ditte.hansen.04@regionh.dk
- Not yet recruiting
Odense University Hospital
Odense, 5000
Morten F Nielsen, MD, PhD, +4522877448, mmfnielsen@health.sdu.dk
Subagini Nagarajah, MD, +4528598621, subagininagarajah3@rsyd.dk
About this study
Official title: Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Patients With Chronic Kidney Disease
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.
Read the detailed description
This study is a 1:1 randomized controlled trial with an intervention for 18 months and a follow up period of 12 months.
The study will explore if treatment with recombinant human parathyroid hormone (PTH) improves bone turnover and bone mineral density (BMD), and thereby prevents the high risk of fracture in patients with chronic kidney disease (CKD).
Disturbed bone metabolism is related to increased risk of cardiovascular disease in patients with CKD. This study also wishes to examine of treatment with recombinant PTH improves cardiovascular parameters.
- Conditions
- Adynamic Bone Disease, Chronic Kidney Diseases, Cardiac Disease, Chronic Kidney Disease-Mineral and Bone Disorder
- Being tested
- Teriparatide, DXA,VFA, X-ray, HR-pQCT, 18-F NAF PET/CT, Bone biopsy, Cardiac tests, Blood and urine samples and physical examination
- Keywords
- Fracture risk, Teriparatide
- Medical subject headings
- Renal Insufficiency, Chronic, Heart Diseases, Chronic Kidney Disease-Mineral and Bone Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
Also called Terrosa
20 micrograms
DXA,VFA, X-ray, HR-pQCT, 18-F NAF PET/CTDiagnostic test
All participants undergo DXA and VFA or X-ray scans 3 times during the study. Some participants (those connected to Herlev) are offered 18F NAF PET/CT scans at baseline and after 12 months and some participants (those connected to Odense University Hospital and Aalborg University Hospital) are offered HR-pQCT scans at baseline and after 12 months. The 18F-NAF PET/CT and HR-pQCT are optional, so it is not a must to have these procedures done to participate in the study.
Bone biopsyProcedure or surgery
All participants are invited to undergo a bone biopsy after 12 months, but it is not a must to have the procedure done to participate in the study.
Cardiac testsDiagnostic test
All participants are invited to undergo 24-hour blood pressure measurements and pulse wave measurements at baseline and after 18 months, but it is not a must to have these procedures done to participate in the study.
Blood and urine samples and physical examinationOther
All participants must undergo a physical examination and deliver blood and urine samples in order to participate in the study.
| Study group | Role | What they receive |
|---|---|---|
| Teriparatide | Experimental | Patients receive teriparatide 20 micrograms once daily for 18 months Receives: Drug: Teriparatide; Diagnostic Test: DXA,VFA, X-ray, HR-pQCT, 18-F NAF PET/CT; Procedure: Bone biopsy; Diagnostic Test: Cardiac tests; Other: Blood and urine samples and physical examination |
| Controls | Other | Controls receive no treatment with teriparatide Receives: Diagnostic Test: DXA,VFA, X-ray, HR-pQCT, 18-F NAF PET/CT; Procedure: Bone biopsy; Diagnostic Test: Cardiac tests; Other: Blood and urine samples and physical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in bone specific alkaline phosphatase (BSAP)
The difference between treated and controls in changes from baseline to 18 months in bone specific alkaline phosphatase
Measured: Baseline and 18 months
Secondary outcomes (27)
Number of patients who no longer has adynamic bone disorder based on a BSAP >21 µg/l
Changes between baseline and 18 months as well as differences between treated and controls.
Measured: Baseline and 18 months. It is also measured through study completion, an average of 30 months
BMD at the lumbar spine, antebrachium, femoral neck and total hip
Changes between baseline and 18 months as well as differences between treated and controls
Measured: Baseline and 18 months. The scan is also performed at 30 months
Incidence of fragility fractures and vertebral fractures assessed using x-ray of columna or vertebral fracture assessment (VFA)
Changes between baseline and 18 months as well as differences between treated and controls
Measured: Baseline and 18 months. The scan is also performed at 30 months
Bone microarchitecture assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT)
Changes between baseline and 12 months as well as differences between treated and controls. The HR-pQCT scan is a voluntary procedure.
Measured: Baseline and 12 months
Volumetric BMD assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT)
Changes between baseline and 12 months as well as differences between treated and controls. The HR-pQCT scan is a voluntary procedure.
Measured: Baseline and 12 months
Bone geometry assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT)
Changes between baseline and 12 months as well as differences between treated and controls. The HR-pQCT scan is a voluntary procedure.
Measured: Baseline and 12 months
Bone strength assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT)
Changes between baseline and 12 months as well as differences between treated and controls. The HR-pQCT scan is a voluntary procedure.
Measured: Baseline and 12 months
Regional bone formation using 18F-Sodium Fluoride Positron Emission Tomography/Computed Tomography (18F-NAF PET/CT)
Changes between baseline and 12 months as well as differences between treated and controls. The 18F-NAF PET/CT is a voluntary procedure.
Measured: Baseline and 12 months
Changes in p-PTH
Changes between baseline and 18 months as well as differences between treated and controls.
Measured: Baseline and 18 months. Some of them are also measured during follow up.
Changes in p-phosphate
Changes between baseline and 18 months as well as differences between treated and controls.
Measured: Baseline and 18 months. Some of them are also measured during follow up.
Changes in p-magnesium
Changes between baseline and 18 months as well as differences between treated and controls.
Measured: Baseline and 18 months. Some of them are also measured during follow up.
Changes in calcium
P-ionised calcium. Changes between baseline and 18 months as well as differences between treated and controls.
Measured: Baseline and 18 months. Some of them are also measured during follow up.
Bone histomorphometry
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.
Measured: 12 months
Changes in Intact Procollagen type 1 N-terminal Propeptide (P1NP)
Changes between baseline and 18 months as well as differences between treated and controls.
Measured: Baseline and 18 months. They are also measured during follow up
Changes in total P1NP
Changes between baseline and 18 months as well as differences between treated and controls.
Measured: Baseline and 18 months. They are also measured during follow up
Changes in Tartrate-Resistant Acid Phosphatase 5b (TRAP5b)
Changes between baseline and 18 months as well as differences between treated and controls.
Measured: Baseline and 18 months. They are also measured during follow up
Changes in sclerostin
Changes between baseline and 18 months as well as differences between treated and controls.
Measured: Baseline and 18 months. They are also measured during follow up
Changes in Receptor Activator of Nuclear factor Kappa-B Ligand (RANKL)
Changes between baseline and 18 months as well as differences between treated and controls.
Measured: Baseline and 18 months. They are also measured during follow up
Changes in Osteoprotegerin (OPG)
Changes between baseline and 18 months as well as differences between treated and controls.
Measured: Baseline and 18 months. They are also measured during follow up
Changes in Fibroblast Growth Factor 23 (FGF-23)
Changes between baseline and 18 months as well as differences between treated and controls.
Measured: Baseline and 18 months. They are also measured during follow up
24-hour blood pressure
Changes between baseline and 18 months as well as differences between treated and controls. These are voluntary procedures.
Measured: Baseline and 18 months
Pulse wave measurements including velocity
Changes between baseline and 18 months as well as differences between treated and controls. These are voluntary procedures.
Measured: Baseline and 18 months
Changes in cardiovascular marker Calciprotein Particles (CPP)/T50
Changes between baseline and 18 months as well as differences between treated and controls.
Measured: Baseline and 18 months
Changes in cardiovascular marker N-Terminal pro B-type Natriuretic Peptide (NT-proBNP)
Changes between baseline and 18 months as well as differences between treated and controls.
Measured: Baseline and 18 months
Adverse reactions
The incidence of adverse reactions in treated patients. This is examined during the entire study.
Measured: From baseline to 18 months
Bone microstructure
Bone mictrostructure by micro-compyter tomography of the bone biopsy
Measured: 12 months
Bone histology
Detailed histology of underlying cellular mechanisms using a combination of immunostainings and advanced in situ hybridizations on the bone biopsy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start15 Dec 2021
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adynamic Bone DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ditte Hansen
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Steno Diabetes Center Copenhagen, Copenhagen University Hospital, Rigshospitalet, Aalborg University Hospital
- Responsible party
- Sponsor-investigator, Ditte Hansen, Herlev Hospital
- Investigators
- Ditte Hansen, MD, PhD, Principal investigator, Department of Nephrology, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522622
- Sponsor's protocol ID
- DANDYNAMIC BONE
- Other IDs
- 2018-003888-56, 2018
- Status last verified
- Apr 2024
- First submitted
- 13 Aug 2020
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As of now we have no plan to share Individual Participant Data (IPD) with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04522622
- Acronym / sponsor ID
- DANDYNAMIC BONE
- Conditions
- Adynamic Bone Disease, Chronic Kidney Diseases, Cardiac Disease, Chronic Kidney Disease-Mineral and Bone Disorder
- Keywords
- Fracture risk, Teriparatide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Ditte HansenUniversity, hospital or other
- Collaborators
- Odense University Hospital, Steno Diabetes Center Copenhagen, Copenhagen University Hospital, Rigshospitalet, Aalborg University Hospital
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a 1:1 randomized controlled trial with an intervention for 18 months and a follow up period of 12 months.
The study will explore if treatment with recombinant human parathyroid hormone (PTH) improves bone turnover and bone mineral density (BMD), and thereby prevents the high risk of fracture in patients with chronic kidney disease (CKD).
Disturbed bone metabolism is related to increased risk of cardiovascular disease in patients with CKD. This study also wishes to examine of treatment with recombinant PTH improves cardiovascular parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teriparatide | Experimental | Drug: Teriparatide, Diagnostic Test: DXA,VFA, X-ray, HR-pQCT, 18-F NAF PET/CT, Procedure: Bone biopsy, Diagnostic Test: Cardiac tests, Other: Blood and urine samples and physical examinationPatients receive teriparatide 20 micrograms once daily for 18 months |
| Controls | Other | Diagnostic Test: DXA,VFA, X-ray, HR-pQCT, 18-F NAF PET/CT, Procedure: Bone biopsy, Diagnostic Test: Cardiac tests, Other: Blood and urine samples and physical examinationControls receive no treatment with teriparatide |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeriparatideAlso: Terrosa20 micrograms | Drug | Teriparatide |
| DXA,VFA, X-ray, HR-pQCT, 18-F NAF PET/CTAll participants undergo DXA and VFA or X-ray scans 3 times during the study. Some participants (those connected to Herlev) are offered 18F NAF PET/CT scans at baseline and after 12 months and some participants (those connected to Odense University Hospital and Aalborg University Hospital) are offered HR-pQCT scans at baseline and after 12 months. The 18F-NAF PET/CT and HR-pQCT are optional, so it is not a must to have these procedures done to participate in the study. | Diagnostic test | Controls, Teriparatide |
| Bone biopsyAll participants are invited to undergo a bone biopsy after 12 months, but it is not a must to have the procedure done to participate in the study. | Procedure or surgery | Controls, Teriparatide |
| Cardiac testsAll participants are invited to undergo 24-hour blood pressure measurements and pulse wave measurements at baseline and after 18 months, but it is not a must to have these procedures done to participate in the study. | Diagnostic test | Controls, Teriparatide |
| Blood and urine samples and physical examinationAll participants must undergo a physical examination and deliver blood and urine samples in order to participate in the study. | Other | Controls, Teriparatide |
Primary outcome
Changes in bone specific alkaline phosphatase (BSAP)
Time frame: Baseline and 18 months
The difference between treated and controls in changes from baseline to 18 months in bone specific alkaline phosphatase
27 secondary outcomes
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
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
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
Bone microarchitecture assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT)
Time frame: Baseline and 12 months
Volumetric BMD assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT)
Time frame: Baseline and 12 months
Bone geometry assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT)
Time frame: Baseline and 12 months
Bone strength assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT)
Time frame: Baseline and 12 months
Regional bone formation using 18F-Sodium Fluoride Positron Emission Tomography/Computed Tomography (18F-NAF PET/CT)
Time frame: Baseline and 12 months
Changes in p-PTH
Time frame: Baseline and 18 months. Some of them are also measured during follow up.
Changes in p-phosphate
Time frame: Baseline and 18 months. Some of them are also measured during follow up.
Changes in p-magnesium
Time frame: Baseline and 18 months. Some of them are also measured during follow up.
Changes in calcium
Time frame: Baseline and 18 months. Some of them are also measured during follow up.
Bone histomorphometry
Time frame: 12 months
Changes in Intact Procollagen type 1 N-terminal Propeptide (P1NP)
Time frame: Baseline and 18 months. They are also measured during follow up
Changes in total P1NP
Time frame: Baseline and 18 months. They are also measured during follow up
Changes in Tartrate-Resistant Acid Phosphatase 5b (TRAP5b)
Time frame: Baseline and 18 months. They are also measured during follow up
Changes in sclerostin
Time frame: Baseline and 18 months. They are also measured during follow up
Changes in Receptor Activator of Nuclear factor Kappa-B Ligand (RANKL)
Time frame: Baseline and 18 months. They are also measured during follow up
Changes in Osteoprotegerin (OPG)
Time frame: Baseline and 18 months. They are also measured during follow up
Changes in Fibroblast Growth Factor 23 (FGF-23)
Time frame: Baseline and 18 months. They are also measured during follow up
24-hour blood pressure
Time frame: Baseline and 18 months
Pulse wave measurements including velocity
Time frame: Baseline and 18 months
Changes in cardiovascular marker Calciprotein Particles (CPP)/T50
Time frame: Baseline and 18 months
Changes in cardiovascular marker N-Terminal pro B-type Natriuretic Peptide (NT-proBNP)
Time frame: Baseline and 18 months
Adverse reactions
Time frame: From baseline to 18 months
Bone microstructure
Time frame: 12 months
Bone histology
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: No. As of now we have no plan to share Individual Participant Data (IPD) with other researchers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ditte Hansen, MD, PhD principal investigator
Department of Nephrology, Herlev and Gentofte Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Teriparatide, DXA,VFA, X-ray, HR-pQCT, 18-F NAF PET/CT and Bone biopsy in people with Adynamic Bone Disease and Chronic Kidney Diseases, run by Ditte Hansen at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabina C Hauge, MD (+4528965887, sabina.chaudhary.hauge@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in bone specific alkaline phosphatase (BSAP) (time frame: Baseline and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.