Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Neoplasms

Symptoms and General Pathology

Heart and Blood Diseases

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Kidney Diseases

Renal Insufficiency

Neoplasm Metastasis

Vascular Diseases

Hyperparathyroidism

Hyperparathyroidism, Secondary

Calcinosis

Vascular Calcification

Neoplastic Processes

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Parathyroid Diseases

Endocrine System Diseases

Chronic Graft Versus Host Disease

All Drugs and Chemicals

Bone Density Conservation Agents

Cinacalcet

Hormones

Calcium

Calcium, Dietary

Hormone Antagonists

Oral Cinacalcet treatment arm, 25mg daily to be administered and gradually step up as required to control iPTH between 2 - 9 times lab reference range, Maximum dose to be given is 100mg daily

Surgical total parathyroidectomy with forearm autografting will be performed for patients randomized to this arm.

oral cinacalcet 25mg once daily as a start and up titrated by 25mg daily according to response in lowering PTH and maximum oral dose allowed is 100mg daily

Surgical total parathyroidectomy with forearm autografting will be performed

Surgical total parathyroidectomy with forearm autografting

Angela YM Wang, MD, PhD

This is a pilot, prospective randomized controlled study with the primary objective to evaluate and compare medical treatment of severe SHPT, namely oral cinacalcet versus surgical treatment, that is, parathyroidectomy with forearm autografting, on the progression of coronary artery and valvular calcification and left ventricular mass index in endstage renal disease patients receiving peritoneal dialysis over 12 months. The change in arterial stiffening, left ventricular volume, aortic valve calcium score and bone mineral density, nutritional status and biochemical parameters, quality of life measures will be evaluated as secondary objectives of this study.

Patients with severe secondary hyperparathyroidism (SHPT) are frequently complicated with vascular calcification. There is some suggestion that subtotal parathyroidectomy may reduce or stabilize vascular calcium scores in dialysis patients. Experimental data suggests that SHPT plays an important role in mediating uraemic arterial disease and that parathyroidectomy largely prevented the development of calcification. Cinacalcet has emerged as a novel therapy for the treatment of SHPT and has been shown to reduce the need for surgical parathyroidectomy. However, their effects on vascular, cardiac, bone and nutrition status have not been evaluated and compared with parathyroidectomy.

Cinacalcet medical treatment versus total parathyroidectomy with forearm autografting surgical treatment

Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients

Comparison of Medical Therapy (Oral Cinacalcet) Versus Surgical Therapy (Total Parathyroidectomy) on Vascular/Valvular Calcification in Chronic Peritoneal Dialysis Patients With Secondary Hyperparathyroidism - A Pilot Randomized Study

change in left ventricular volume and ejection fraction

Change in aortic valve and mitral valve calcium score

change in augmentation index and heart rate adjusted augmentation index

change in bone mineral density at forearm, spine and femur

Kidney Disease Outcome Quality Initiatives (KDOQI QOL domain scores)

Change in biochemical parameter Serum calcium and phosphorus

Change in biochemical parameter Parathyroid hormone

Change in biochemical parameter alkaline phosphatase

CHange in biochemical parameter serum albumin

change in systolic and diastolic blood pressure

The University of Hong Kong

Honorary Associate Professor

Blood and Lymph Conditions

Kidney Failure, Chronic

Anemia

Hematologic Diseases

Renal Insufficiency, Chronic

Chronic Disease

Disease Attributes

Micronutrients

Gastrointestinal Agents

Vitamins

Vitamin D

Cholecalciferol

Sevelamer

Calcium acetate

Aluminum hydroxide, magnesium hydroxide, drug combination

Trace Elements

Vitamin D3

Calciferol

Control group: standard care. The iPTH target in this group is 300-540 pg/ml

Optimal CKD-MBD control: in this group the PTH target is150-300 pg/ml to be achieved with a therapeutic algorithm

Standard care. Patients allocated to this study arm will be treated with all drugs available for PTH control (at the investigator discretion) to obtain a iPTH of 300-540 pg/ml.

standard care

Optimal care. Patients allocated to this study arm will be treated with all drugs available for PTH control (at the investigator discretion - see therapeutic algorithm) to obtain a iPTH of less than 300 pg/ml.

Optimal (I. iPTH control: Zemplar®,Mimpara®; phosphorous control: Renvela®, Phoslo®, Osvaren®, Foznol®,Maalox®; calcium control: calcium and vitamin D

Antonio Bellasi, MD

Simona Urbano

Claudio Minoretti, MD

Clinical study aimed at improving anemia management in End Stage Renal Disease Patient (ESRD) on maintenance Hemodialysis with evidence of Chronic Kidney disease Mineral Bone Disorder (CKD-MBD)

Anemia is one of the most worrisome complications of Chronic Kidney Disease (CKD). Numerous prospective studies have repeatedly documented an increase risk of morbidity and mortality associated with lower levels of hemoglobin (Hb). Hence the international guidelines on patient care suggest the use of Erythropoietin Stimulating Agents (ESA), iron, folates supplementation for anemia correction.

However, recent randomized controlled trials (RCT) have demonstrated that hemoglobin correction to normal levels increases the risk of major cardiovascular (CV) events. Though, the reasons are still unclear, the cumulative ESA dose may at least partly explain these findings suggesting limiting ESA to the minimal dose allowed to achieve the suggested Hb targets in ESRD patients.

Among other factors, CKD-MBD has been repeatedly associated with poor more severe anemia and higher dose of ESA. However, the latest Kidney Disease: Improving Global Outcomes (KDIGO) guidelines on CKD-MBD management suggest a higher reference target for intact parathyroid hormone (iPTH) (2-9 fold the upper level of the normal range) when compared to the National Kidney Foundation (NKF) guidelines published in 2003 (150-300 pg/ml).

A few observational studies suggest a linear inverse association between intact iPTH and ESA dose even for iPTH value within the iPTH target level proposed by the KDIGO working group. Similarly, a large body of evidence supports the notion that the higher the iPTH the faster the CV system deterioration in ESRD.

Aim of the study is to test whether a tighter iPTH control to achieve a iPTH level lower than 300 pg/ml vs iPTH levels between 300-540 pg/ml is associated with a ESA dose reduction and a slower CV system deterioration in ESRD patients receiving dialysis.

STUDY DESIGN Pilot, single center, open label with blinded end point (PROBE-Prospective Randomized Open Blinded End-Point) aimed at improving patient care.

Eligible patients will be randomized (1:1) to either:

(A) Control group: standard care. The iPTH target in this group is 300-540 pg/ml (B) Optimal CKD-MBD control: in this group the iPTH target is150-300 pg/ml to be achieved with a therapeutic algorithm.

TREATMENTS

All patients will be randomized (1:1) to either:

(A) Control group: standard care. The iPTH target in this group is 300-540 pg/ml.

(B) Optimal CKD-MBD control:: in this group the iPTH target is 150-300 pg/ml to be achieved with a therapeutic algorithm:

I. iPTH control: in order to achieve the iPTH target (150-300 pg/ml), all patients will receive 400 IU/day of vitamin-25-OH-D (25OHD) and a flexible dose of any active vitamin D available in Italy (calcitriol and paricalcitol-"Zemplar®") at the maximum dose of 6 mcg/week of paricalcitol("Zemplar®")of equivalent (see existing conversion table). Patients will also receive a flexible dose of cinacalcet("Mimpara®") to a maximum dose of 90 mg/day.

II. Phosphorous control: all patients need to achieve a serum phosphorous level lower than 5.5 mg/dl. All available phosphate binders are allowed \[sevelamer("Renvela®"), calcium carbonate, calcium acetate("Phoslo®"), calcium acetate/magnesium carbonate ("Osvaren®"), lanthanum carbonate "Foznol®"). A rescue therapy with aluminum("Maalox®") is allowed for no more than 30 days.

III. Serum calcium control: the suggested target is less than 9.5 mg/dl. In case of serum calcium greater than 9.5 mg/dl the calcium and vitamin D dose should be lowered in order to lower the risk of vascular calcification deposition and progression

Optimal Anemia Treatment in End Stage Renal Disease (ERSD)

Single-center, Open-label, Randomized Study of Anemia Management Improvement in End Stage Renal Disease (ESRD) Patients With Secondary Hyperparathyroidism

Primary objective: to test whether a tighter PTH control to achieve a PTH level lower than 300 pg/ml vs PTH levels between 300-540 pg/ml is associated with a lower ESA dose use to achieve the target Hb of 10.0-11.5 g/dl

Secondary objective: to test whether a tighter PTH control to achieve a PTH level lower than 300 pg/ml vs PTH levels between 300-540 pg/ml is associated with a better iron storage and mobilization.

Secondary objective: to test whether a tighter PTH control to achieve a PTH level lower than 300 pg/ml vs PTH levels between 300-540 pg/ml is associated with cardiac valves deposition and progression attenuation.

Secondary objective: to test whether a tighter PTH control to achieve a PTH level lower than 300 pg/ml vs PTH levels between 300-540 pg/ml is associated with arterial stiffness increase attenuation

Secondary objective: to test whether a tighter PTH control to achieve a PTH level lower than 300 pg/ml vs PTH levels between 300-540 pg/ml is associated with a better CKD-MBD control

Amgen

Azienda Ospedaliera Sant'Anna

Skin and Connective Tissue Diseases

Breast Neoplasms

Metabolic Diseases

Calcium Metabolism Disorders

944 participants will receive a post-mammography results letter which includes information on their BAC results.

944 participants will receive a post-mammography results letter without BAC information, which is the current standard of care. These patients will receive BAC information following study completion (approximately 6 months after mammography).

The BAC-Enhanced Letter intervention includes enhancing the standard mammography results letter with a few additional lines of text informing patients of their personal BAC status.

BAC-Enhanced Letter

Patients randomized to this group will receive a standard post-mammography results letter which does not include any information about their personal BAC status. However, participants randomized to this group will be informed of their personal BAC findings at the end of their study participation (approximately 6 months after mammography).

Waitlist Control

Crystalinda Rapozo

Julie B. Schnur, Ph.D.

Guy H. Montgomery

Guy H. Montgomery, Ph.D.

The purpose of this research study is to determine the potential benefits of adding information on patients' breast arterial calcification (BAC) results to the standard results letter women receive after mammography. In addition to looking for potential breast cancer, research shows that mammograms can also detect the presence of calcifications within the breast arteries. Those calcifications can be associated with coronary artery disease. Right now, women are not routinely told whether or not they have BAC; that is, it's not part of standard practice to communicate that information to patients. However, previous research has suggested that patients would like to be informed about their BAC status more often. In this study, the team has two goals. First, the team wants to measure the rates of BAC in a large, diverse group of 14,875 women. Because most of the past research on BAC has largely been focused on White mammography patients, the researchers feel it is important to see if the results are similar or different in a more racially and ethnically diverse sample.

Second, the study team wants to understand the effects of giving women information on their BAC results as part of their standard post-mammography letter. Specifically, the study team wants to see how sharing that information might affect women's healthcare choices and lifestyle. The research will include 1,888 women in this second part of the study, which will be the first in the literature to explore women's reactions to BAC information. If research shows that women find the information useful, BAC information may be given to women regularly in the future.

Mammography and Breast Arterial Calcification: An Information-Sharing Trial

Enhancing the Public Health Benefits of Mammography Screening by Informing Women of Both Breast Cancer and Breast Arterial Calcification Results: A Randomized Trial to Promote Cardiovascular Health

There currently isn't a plan to share individual participant data (IPD) with other researchers as this is a single-center trial and all study investigators and personnel are affiliated with Mount Sinai.

Patients will be asked a YES/NO question asking them to report whether they have seen a healthcare provider to talk about their heart or coronary artery disease in the last six months. Patient's self-report responses will be confirmed via medical record review.

The Healthy Heart Score is a survey to assess patients' heart healthy behaviors. It assesses age, smoking, body mass index, exercise, alcohol, and a composite diet score. A higher score indicates a greater risk of cardiovascular disease.

Score has gender-specific algorithm that estimates 20-year CVD risk (https://healthyheartscore.sph.harvard.edu/) (DOI: 10.1161/JAHA.114.000954):

20-yr CVD risk (%) "Healthy Heart Score" = \[1 - 0. 9660 (exp \[W- 6.57301)\] × 100% where W= 0.10820 x age + 0.15285 (if past smoker) + 0.90138 (if current smoker) + 0.04676 × BMI - 0.01923 × g/d of alcohol + 0.0004 × (g/d of alcohol)2- 0.029251 × hrs/wk of physical activity - 0.05113 × diet score\* 20-yr CVD risk (%) "Healthy Heart Score" = \[1 - 0. 96368 (exp \[W-7.2437)\] × 100% where W= 0.13580 x age- 0.0005 x (age)2 + 0.06979 (if past smoker) + 0.42305 (if current smoker) +0.07424 × BMI - 0.00898 × g/d of alcohol + 0.0001 × (g/d of alcohol)2- 0.01755 × hrs/wk of physical activity - 0.06691 × diet score

Participants will respond to a single, self-report item (adapted from the 2019 NHIS survey item) which will ask if they have been told by a doctor or other health professional that they had coronary artery disease in the last 6 months. The item will be rated as, "yes, no, or don't know." Self-reported diagnosis will be confirmed via medical record review.

Illness representations will be assessed using the IPQ-R which have been adapted to include an addendum of Cardiovascular-Disease Related Worry Scale questions. Participants will be asked to rate items related to personal beliefs about CAD with regard to causal beliefs and on 8 subscales: identity (scale 0-13); timeline (scale 6-30); consequences (scale 6-30); personal control (scale 6-30); treatment control (scale 5-25); illness coherence (scale5-25); timeline cyclical (scale 4-20); and emotional representations (scale 6-30); and CVD related worry scale (scale3-13). Full scale from 41-216, higher scores represent a higher number of symptoms related to CAD, more positive beliefs about the controllability of disease, and a greater personal understanding of the condition.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients	NCT01447368	Kidney Failure Secondary Hyper... Vascular Diseas...	Cinacalcet Surgical total ...	18 Years - 75 Years	The University of Hong Kong
Optimal Anemia Treatment in End Stage Renal Disease (ERSD)	NCT02273570	Hyperparathyroi...	standard care Optimal (I. iPT...	18 Years -	Azienda Ospedaliera Sant'Anna
Mammography and Breast Arterial Calcification: An Information-Sharing Trial	NCT04983875	Mammography Vascular Calcif...	BAC-Enhanced Le... Waitlist Contro...	40 Years -	Icahn School of Medicine at Mount Sinai
Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients	NCT01447368	Kidney Failure Secondary Hyper... Vascular Diseas...	Cinacalcet Surgical total ...	18 Years - 75 Years	The University of Hong Kong

Spots Global Cancer Trial Database for vascular calcification