NCT04522622

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

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Ditte Hansen · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-12-15
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2020-08-21
• Last updated: 2024-04-23

Locations

4 sites across 1 country: Denmark