RecruitingPhase 4NCT04522622

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

Sponsor

Ditte Hansen

Enrollment

48 participants

Start Date

Dec 15, 2021

Study Type

INTERVENTIONAL

Conditions

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

Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether parathyroid hormone (PTH) injections can improve bone strength and reduce fracture risk in people with advanced chronic kidney disease who have very low bone turnover — a condition called adynamic bone disorder — where the bones stop renewing themselves properly. **You may be eligible if...** - You are 18 or older - You have advanced chronic kidney disease (stage 4-5, including dialysis patients) - A bone density scan (DXA) shows you have low bone density - A bone biopsy has confirmed adynamic bone disorder (very low bone turnover) **You may NOT be eligible if...** - You have high parathyroid hormone levels (secondary hyperparathyroidism) - You have had bone cancer or radiation to your bones - You are pregnant or breastfeeding - You have an elevated risk of bone cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTeriparatide

20 micrograms

DIAGNOSTIC_TESTDXA,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.

PROCEDUREBone 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_TESTCardiac 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.

OTHERBlood 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.