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Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease | Clinical Trials | Clareo Health

RECRUITINGPHASE4

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

NCT04522622•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.

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.

Eligibility

Age

18 - 120 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥18 years
•CKD stage 4-5D (eGFR ≤29 ml/min) according to Kidney Disease Improving Global Outcomes(KDIGO) definition
•DXA scan with a T-score at the total hip, femoral neck or lumbar spine (L1-4) ≤-2 (or Z-score ≤-2) in a minimum of 2 vertebraes (for patients with active oral prednisolone treatment ≥ 5 mg/day for minimum 3 months the T-score or Z-score limit i \< -1) and/or former fragility fracture (vertebral, hip, for- or upper arm, ankle) assessed with VFA or x-ray of the columna
•Patients with expected adynamic bone disorder, based on BSAP≤21 µg/l or biopsy-verified low bone turnover

Exclusion Criteria

•Hypercalcemia defined as sustained ionized calcium \>1.35 mmol/l
•Previous fracture withon the last 6 months \*Patients may be rescreened after the 6 months
•Previous calciphylaxis
•Thyroid disturbances not adequately treated based on the opinion by the clinician \*Patients may be rescreened after treatment optimization
•Treatment with digoxin
•Paget's disease or other metabolic bone disorders
•Antiresorptive or bone anabolic medication during the last 24 months (for bisphosphonates it is only during the last 12 months)
•Former or present malignant disease (except skin basal or planocellular carcinoma)
•Previous external beam or implant radiation therapy to the skeleton
•Patients who have undergone a kidney transplantation within the last 12 months
+11 more criteria

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

Key Dates

Start Date

December 15, 2021

Primary Completion Date

September 1, 2026

Completion Date

September 1, 2027

Last Updated

April 23, 2024

Enrollment

ESTIMATED participants

Conditions

Adynamic Bone DiseaseChronic Kidney DiseasesCardiac DiseaseChronic Kidney Disease-Mineral and Bone Disorder

Interventions

Teriparatide

DRUG

DXA,VFA, X-ray, HR-pQCT, 18-F NAF PET/CT

DIAGNOSTIC_TEST

Bone biopsy

PROCEDURE

Cardiac tests

DIAGNOSTIC_TEST

Blood and urine samples and physical examination

OTHER

Contacts

Sabina C Hauge, MD

CONTACT

+4528965887 sabina.chaudhary.hauge@regionh.dk

Ditte Hansen, MD, PhD

CONTACT

+4538682056 ditte.hansen.04@regionh.dk

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 23, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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