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RECRUITING
NCT04522622
PHASE4

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

Sponsor: Ditte Hansen

View on ClinicalTrials.gov

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

Interventions

DRUG

Teriparatide

20 micrograms

DIAGNOSTIC_TEST

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.

PROCEDURE

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.

DIAGNOSTIC_TEST

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.

OTHER

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