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Free access

Dana Holováčová, Martin Kužma, Zdenko Killinger, and Juraj Payer


The purpose of this study was to assess changes in the cross-sectional area (CSA) of nervus medianus by ultrasound in newly diagnosed primary hypothyroid patients after thyroxine replacement treatment.

Patients and methods

The cohort comprised 30 patients with newly diagnosed primary autoimmune hypothyroidism. These were subsequently compared with 30 controls, matched for sex, BMI and age. Ultrasound evaluation, including measurement of CSA at the level of the pisiform bone or tunnel inlet was performed at baseline and after 3months. A CSA threshold of more than 10mm2 was considered pathological.


CSA was increased in patients compared with controls (9.8±0.7mm2 vs 7.2±1.1mm2; P<0.001). Thyroxin substitution increased fT4 levels (baseline, 11.0±0.6pmol/L vs 15.5±0.4pmol/L; P<0.001) and decreased TSH (baseline, 23.9±6.0mIU/L vs 2.7±0.2mIU/L; P<0.001). Thyroxine treatment decreased CSA to 8.4mm2±0.3mm2 (P=0.033). Before treatment, four patients experienced distal paresthesia in the median nerve distribution area. Increased CSA pathognomonic for carpal tunnel syndrome found in two symptomatic patients normalized after 3months. No clinical symptoms were observed after 3months. A positive correlation was found between TSH and CSA (R=0.155, P=0.05) before treatment.


Our study demonstrates that increase in median nerve CSA caused by primary autoimmune hypothyroidism can be fully reversible after achieving target levels of TSH and fT4.

Free access

Martin Kužma, Peter Vaňuga, Ivana Ságová, Dušan Pávai, Peter Jackuliak, Zdenko Killinger, Neil C Binkley, Renaud Winzenrieth, Harry K Genant, and Juraj Payer


Impaired bone microarchitecture is involved in vertebral fracture (VF) development among acromegaly patients.

Aim of the study

Comparison of DXA-derived bone parameters, areal BMD (aBMD), trabecular bone score (TBS) and 3D-SHAPER parameters in acromegaly patients with healthy controls.


This cross-sectional study evaluated acromegaly patients and a control group of healthy subjects. In all subjects, a single measurement of pituitary axis hormone levels, bone turnover markers, aBMD, (total hip (TH) and lumbar spine (LS)), TBS and 3D-SHAPER of the proximal femur region was performed. All subjects underwent DXA assessment of VF using the semiquantitative approach.


One hundred six patients with acromegaly (mean age 56.6 years, BMI 30.2 kg/m2) and 104 control subjects (mean age 54.06 years, 28.4 BMI kg/m2) were included. After adjustment for weight, LS aBMD, TBS and TH trabecular volumetric BMD (vBMD) remained lower (P = 0.0048, <0.0001 and <0.0001, respectively) while cortical thickness (Cth) at TH and neck remained thicker (P = 0.006) in acromegaly patients compared with controls. The best multivariate model (model 1) discriminating patients with and without acromegaly included TBS, TH trabecular vBMD and TH Cth parameters (all P < 0.05). Twenty-two VFs (13 acromegaly subjects) were recognized. In these subjects after adjustment for age, FN aBMD, TH cortical sBMD and TH cortical vBMD remained significantly associated with the prevalent VF (OR = 2.69 (1.07–6.78), 2.84 (1.24–6.51) and 2.38 (1.11–5.10) for neck aBMD, TH cortical sBMD and TH cortical vBMD respectively)). The AUCs were similar for each parameter in this model.


Acromegaly patients, regardless of VF presence, have lower trabecular bone quantitative parameters, but those with VFs had decreased cortical density.

Open access

Christian J Strasburger, Peter Vanuga, Juraj Payer, Marija Pfeifer, Vera Popovic, László Bajnok, Miklós Góth, Veˇra Olšovská, L‘udmila Trejbalová, Janos Vadasz, Eyal Fima, Ronit Koren, Leanne Amitzi, Martin Bidlingmaier, Oren Hershkovitz, Gili Hart, and Beverly M K Biller


Growth hormone (GH) replacement therapy currently requires daily injections, which may cause distress and low compliance. C-terminal peptide (CTP)-modified growth hormone (MOD-4023) is being developed as a once-weekly dosing regimen in patients with GH deficiency (GHD). This study’s objective is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of MOD-4023 administered once-weekly in GHD adults.


54 adults with GHD currently treated with daily GH were normalized and randomized into 4 weekly dosing cohorts of MOD-4023 at 18.5%, 37%, 55.5% or 123.4% of individual cumulative weekly molar hGH dose. The study included 2 stages: Stage A assessed the effectiveness and PK/PD profiles of the 4 dosing regimens of MOD-4023. Stage B was an extension period of once-weekly MOD-4023 administration (61.7% molar hGH content) to collect further safety data and confirm the results from Stage A.


Dose-dependent response was observed for both PK and PD data of weekly MOD-4023 treatment. Insulin-like growth factor I (IGF-I) SDS levels were maintained within normal range. The 18.5% cohort was discontinued due to low efficacy. MOD-4023 was well tolerated and exhibited favorable safety profile in all dose cohorts. The reported adverse events were consistent with known GH-related side effects.


Once-weekly MOD-4023 administration in GHD adults was found to be clinically effective while maintaining a favorable safety profile and may obviate the need for daily injections. Weekly GH injections may improve compliance and overall outcome. The promising results achieved in this Phase 2 study led to a pivotal Phase 3 trial, which is currently ongoing.