Diagnosis and treatment of bone disease in patients with chronic kidney disease

Phase 1

• Conditions: MedDRA version: 21.0Level: LLTClassification code 10060881Term: Adynamic bone diseaseSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2018-003888-56-DK
• Lead Sponsor: Department of Nephrology, Herlev & Gentofte Hospital, Herlev Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-02
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

? Age =18 years
? CKD stage 4-5D (eGFR =2930 ml/min) according to KDIGO (Kidney Disease Improving Global Outcome) definition
? DEXA 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 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 33
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33

Exclusion Criteria

? Hypercalcemia defined as sustained ionized calcium >1.35 mmol/l
? Previous fracture within 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
? 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
? Kidney transplanted patients
? Oral prednisolone treatment exceeding a total of 450 mg during the last 6 months or active oral prednisolone treatment with a daily dose of > 5 mg
? 25 hydroxyvitamin D2 and D3 <50 nmol/l *Patients may be rescreened after correction
? Inability to administer teriparatide
? Reduced liver function *ALAT >3x upper limit of normal or bilirubin > 2x upper limit of normal
? Pregnancy, lactation or fertile women * Post-menopausal females are not considered fertile not using safe anticonception (the following contraceptive methods are considered appropriate: Intrauterine device (IUD) or hormonal anticontraceptive (oral contraceptives, implant, transdermal patches, vaginal ring or depot injection)).
? Hypersensitivity to the active substance in teriparatide or to any of the excipients or content
? Inability to provide informed consent
? Medical conditions or treatments that may interfere with assessments of the outcomes of the trial
? Drug or alcohol abuse
? Unable to participate in a clinical study based on the judgement by the local investigator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The study will explore if treatment with recombinant human parathyroid hormone (PTH) improves bone turnover and bone mineral density (BMD) and thereby prevent the high risk of fracture in patients with chronic kidney disease (CKD).<br>;Secondary Objective: Disturbed bone metabolism is related to increased risk of cardiovascular disease in patients with CKD. The study will examine if treatment with recombinant PTH improves cardiovascular parameters.<br>;Primary end point(s): The primary endpoint is the difference between the two groups (treated versus controls) in changes in BSAP after 18 months. ;Timepoint(s) of evaluation of this end point: Evalutaion of this endpoint is after 18 months after inclusion