A Phase 4 interventional study of Teriparatide and DXA,VFA, X-ray, HR-pQCT, 18-F NAF PET/CT in Adynamic Bone Disease, Chronic Kidney Diseases and Cardiac Disease, sponsored by Ditte Hansen. Recruiting at 4 sites in Denmark. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2024-04-23.
Sponsored by Ditte Hansen · Phase 4, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 116 studies in Renal Insufficiency, Chronic with a site in Denmark — 27 open to participants now, 35 under way, 9 of them phase 3. Renal Insufficiency, Chronic · Denmark.
Among the 116 studies in Renal Insufficiency, Chronic with a site in Denmark, this one is the 67th largest by planned enrollment of the 90 interventional ones that give a count, is one of 12 that started in 2021, is one of 8 in phase 4, reaches primary completion later than 10 of the 34 other live ones, and was the 62nd registered.
3,095 studies on the registry are indexed under Renal Insufficiency, Chronic; 701 are open to participants now.
Browse Renal Insufficiency, Chronic studies →27 of the 116 studies in Renal Insufficiency, Chronic with a site in Denmark are open now. Recruiting first, the newest first:
Odense University Hospital · Sites in Denmark
Ages 18+
AstraZeneca · Sites in Denmark, United States, Argentina and 34 more countries
Ages 18+
Odense University Hospital · Sites in Denmark
Ages 18+ · Healthy volunteers
Steno Diabetes Center Copenhagen · Sites in Denmark
Ages 18–74
Herlev Hospital · Sites in Denmark
Ages 18+
A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →
Of the 435 Renal Insufficiency, Chronic studies recruiting now, 244 (56%) set no upper age limit and 111 (26%) stop at 75 or younger; 45 take children under 18; 80 take healthy volunteers.
This study: 18 Years to 120 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
116 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 24 · Phase 3 32 · Phase 4 8
First in 2002; this study’s year is marked. 12 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 48 is below the median of 73 across 2,162 interventional studies indexed under Renal Insufficiency, Chronic.
Median enrollment 136 across the 90 interventional studies, 321 across the 26 observational. Of the 73 that completed or were terminated, 28 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
52 of 116 have an industry lead sponsor. The 10 most frequent:
Ditte Hansen is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Ditte Hansen has 1 study filed under Renal Insufficiency, Chronic — fewer than ten, so there is no comparison to draw.
8 of the studies in Renal Insufficiency, Chronic with a site in Denmark that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06531824Phase 3Boehringer IngelheimEASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin) | 2026-12-31 |
| NCT05196035Phase 3BayerA Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria | 2027-04-10 |
| NCT05970172Phase 3Astellas Pharma Global Development, Inc.A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease | 2027-10-30 |
| NCT07026539University of AarhusEffect of Treatment With Finerenone on Cardio-Renal Target Organ Damage in Patients With Type 2 Diabetes. | 2026-12-31 |
| NCT06823115Indiana UniversityAssessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0 | 2027-01 |
Add all 8 to your calendar (.ics) → With an account.
Among the 116 studies in Renal Insufficiency, Chronic with a site in Denmark, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive teriparatide 20 micrograms once daily for 18 months
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 receive no treatment with 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
20 micrograms
Also known as: Terrosa
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.
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.
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.
All participants must undergo a physical examination and deliver blood and urine samples in order to participate in the study.
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
Time frame: Baseline and 18 months
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.
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
Changes between baseline and 18 months as well as differences between treated and controls
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)
Changes between baseline and 18 months as well as differences between treated and controls
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)
Changes between baseline and 12 months as well as differences between treated and controls. The HR-pQCT scan is a voluntary procedure.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 12 months
Changes in p-PTH
Changes between baseline and 18 months as well as differences between treated and controls.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 18 months
Adverse reactions
The incidence of adverse reactions in treated patients. This is examined during the entire study.
Time frame: From baseline to 18 months
Bone microstructure
Bone mictrostructure by micro-compyter tomography of the bone biopsy
Time frame: 12 months
Bone histology
Detailed histology of underlying cellular mechanisms using a combination of immunostainings and advanced in situ hybridizations on the bone biopsy
Time frame: 12 months
Plan to share: No — As of now we have no plan to share Individual Participant Data (IPD) with other researchers
No publications or documents are linked to this record.
Started Dec 2021 (actual). Primary completion is estimated for Sep 2026, 56 months after the start.
Of 100 non-industry phase 4 interventional studies under Renal Insufficiency, Chronic, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 67. This study's planned 56 months is above that.
Counting every sponsor, half of 116 studies reached it within 43 months; a quarter within 22 and three quarters within 67.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Teriparatide
Renal Insufficiency, Chronic →
Ditte Hansen