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Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease
Sponsor: Ditte Hansen
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.
Official title: Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Patients With Chronic Kidney Disease
Key Details
Gender
All
Age Range
18 Years - 120 Years
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2021-12-15
Completion Date
2027-09-01
Last Updated
2024-04-23
Healthy Volunteers
No
Conditions
Interventions
Teriparatide
20 micrograms
DXA,VFA, X-ray, HR-pQCT, 18-F NAF PET/CT
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 biopsy
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 tests
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 examination
All participants must undergo a physical examination and deliver blood and urine samples in order to participate in the study.
Locations (4)
Aalborg University Hospital
Aalborg, Denmark
Steno Diabetes Center Copenhagen
Gentofte Municipality, Denmark
Herlev and Gentofte Hospital, Herlev Hospital
Herlev, Denmark
Odense University Hospital
Odense, Denmark