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

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.

Conditions

• Adynamic Bone Disease
• Chronic Kidney Diseases
• Cardiac Disease
• Chronic Kidney Disease-Mineral and Bone Disorder

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.

Sponsors & Collaborators

• Odense University Hospital

  collaborator OTHER

• Steno Diabetes Center Copenhagen

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Ditte Hansen

  lead OTHER

Principal Investigators

• Ditte Hansen, MD, PhD · Department of Nephrology, Herlev and Gentofte Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-15

Primary Completion

2026-09-01

Completion

2027-09-01

Countries

• Denmark

Study Locations