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

Who is this study for? Patients with Adynamic Bone Disorder with Chronic Kidney Disease
What treatments are being studied? Dual Energy X-ray Absorptiometry (DXA), X-ray, High-Resolution peripheral Quantitative Computed Tomography (HR-pQCT), 18F-Sodium Fluoride Positron Emission Tomography/CT (18-F NAF PET/CT)+Bone Biopsy+Cardiac Tests+Blood Samples and Physical Examination
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure, Drug, Diagnostic test, Other
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Aalborg University Hospital
NOT_YET_RECRUITING
Aalborg
Steno Diabetes Center Copenhagen
NOT_YET_RECRUITING
Gentofte Municipality
Herlev and Gentofte Hospital, Herlev Hospital
RECRUITING
Herlev
Odense University Hospital
NOT_YET_RECRUITING
Odense
Contact Information
Primary
Sabina C Hauge, MD
sabina.chaudhary.hauge@regionh.dk
+4528965887
Backup
Ditte Hansen, MD, PhD
ditte.hansen.04@regionh.dk
+4538682056
Time Frame
Start Date: 2021-12-15
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 48
Treatments
Experimental: Teriparatide
Patients receive teriparatide 20 micrograms once daily for 18 months
Other: Controls
Controls receive no treatment with teriparatide
Sponsors
Collaborators: Steno Diabetes Center Copenhagen, Odense University Hospital, Aalborg University Hospital, Rigshospitalet, Denmark
Leads: Ditte Hansen

This content was sourced from clinicaltrials.gov