Neoplasms

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Gland and Hormone Related Diseases

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Hyperparathyroidism

Hyperparathyroidism, Secondary

Recurrence

Neoplastic Processes

Parathyroid Diseases

Endocrine System Diseases

Patients who have been successfully operated on with total parathyroidectomy for symptomatic secondary hyperparathyroidism and their PTH levels are below 72 pg/dL within one week after surgery.

Patients who have had regular dialysis and their iPTH levels are around 500 pg/dL

Patients should receive total parathyroidectomy plus bilateral thymectomy and autotransplantation

parathyroidectomy plus bilateral thymectomy and autotransplantation

Chang Huang-Chih, MD

Chen Jib-Bor, MD

Lai Chi-Chih, MD

In this study, investigators measure patient's voice frequency, swallowing function, and O2 desaturation of the 6 mins walking test before surgery and 4 months after surgery, to find the increase of voice frequency, and swallowing function and the decrease of O2 desaturation.

This was a prospective case-control study. From July 2017 to Dec. 2018, investigators recruited 38 patients, who had undergone a successful operation of total parathyroidectomy and bilateral thymectomy (TPxBT) plus autotransplantation for symptomatic secondary hyperparathyroidism as the study group. In the same period 4 patients who had a surgical failure were excluded from the study. Indications for surgery were patients who had undergone long-term regular hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), with serum levels of Ca \> 10.1 mg/dL, P \> 5.5 mg/dL, alkaline phosphatase (Alk-ptase) \> 94 U/L and intact parathyroid hormone(iPTH) \> 800 pg/mL and with symptoms and signs such as skin itching, bone pain, general weakness, insomnia and T-score of bone mineral density (BMD) (the lowest T-score of lumbar spine 1-4, global femur, femoral neck, radial 1/3, and global radius) \< -2.5. During surgery, Total parathyroidectomy and bilateral thymectomy was performed plus autotranplantation of 100 mg of hyperplastic parathyroid tissue to the subcutaneous tissue of the forearm without harboring an arteriovenous fistula.

Ten patients with regular hemodialysis who had developed mild secondary hyperparathyroidism (iPTH around 500 pg/mL) but did not undergo parathyroidectomy were recruited as the control group.

Investigators recorded patients' age, symptoms, gender, body mass index (BMI) and measured serum levels of Ca, P, Alk-ptase and iPTH, and BMD (T-score). The Investigators also recorded patients' voice quality, airway invasion during swallowing and pulmonary functions before surgery and 4 months after surgery to find the changes after surgery. In the control group, investigators recorded and measured these items at baseline and 4 months later.

At 1 week after surgery, serum Ca, P, Alk-ptase and iPTH levels were measured again to make sure that the operation was successful. A successful operation was defined as iPTH levels \< 72 pg/mL within 1 week after surgery. Four patients were excluded from this study with a surgical failure in the same period.

The perceptual evaluation of voice quality such as speech impairment and speech quality by means of multidimensional clinical measurements based on auditory methods with grade, hoarseness, roughness, breathiness, asthenia, and strain (GRBAS) on a scale (0-3) (normal-high degree) were performed by the ear, nose, and throat specialist (Dr. Lai, C.C.). Voice handicap index (VHI-10) (\>11, abnormal) and eating assessment tool (EAT-10) (≥ 3, abnormal) were evaluated by patients themselves.

Acoustic and aerodynamic measurements were applied to recordings of each subject producing sustained vowel productions in a soundproof room. Acoustic variables including jitter (Jitt), shimmer (ShdB), noise-to-harmonic ratio (NHR), fundamental frequency (Fo), and high pitch were measured using computerized speech laboratory (Core Model SCL # 4300B, KayPENTAX Elementries, Lincoln park, NJ).

The maximal phonation time and s/z ratio were measured with circumferentially vented pneumotachography mask and differential transducers of the Aerophone system (Aerophone II, Model 6800, KayPENTAX Elementrics). Vocal cord mobility, vocal cord closure (complete or incomplete), airway invasion during swallowing were inspected with fiber-optic endoscopy to show premature spillage, penetration-aspiration scale levels (1-8) (no entry of material into the larynx or trachea-material enter the airway passes below vocal folds and no effort is made to eject) (\>1, abnormal). The Yale pharyngeal residue severity rating scale for vallecula (0-4) (non-trace-mild-moderate-severe) and pyriform sinus (0-4) were also performed by the ENT specialist.

The specialist of chest medicine (Dr. Chang, H.C.) performed pulmonary function tests including forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), bronchodilator test (BDT) (a positive response to BDT defined by the American Thoracic Society as an increase in FEV1 or FVC ≥ 12% and 200 ml), total lung capacity (TLC), and alveolar volume (VA) using MasterScope (Jaeger, VIASYS healthcare GmbH, Höchberg, Germany), and diffusion capacity of the lung for carbon monoxide (DLCO) using Vmax Autobox (SensorMedics, a subsidiary of VIASYS healthcare, California, USA). The 6 minutes walking test (6MWT) was also performed to evaluate distance (meter) and O2 desaturation (differences of O2 saturation between pre- and post-tests) (defined as positive if O2 desaturation ≧ 4%).

Pulmonary Function, Voice and Swallowing Symptoms After Parathyroidectomy

Changes of Pulmonary Function, Voice and Swallowing Symptoms After Total Parathyroidectomy for Secondary Hyperparathyroidism in the Presence of Intact Recurrent Laryngeal Nerve

After successful surgery, patients were recruited in the study, and we excluded patients with a surgical failure.

speech impairment and speech quality were evaluated with GRBAS on a scale (0-3), VHI-10 (\>11, abnormal) and (EAT-10) (≥ 3, abnormal) .

\*GRBAS (grade, roughness, breathiness, asthenia, strain) scale grades hoarseness, roughness, breathiness, aesthenia (weakness), and strain on a scale of 0-3 0 = normal, 1 = mild degree, 2 = moderate degree, and 3 = high degree

speech impairment and speech quality were evaluated with voice handicap index (VHI-10) (\>11, abnormal) 0-4 Rating Scale 0 = Normal

1. = Almost Normal
2. = Sometimes
3. = Abnormal
4. = Always

speech impairment and speech quality were evaluated with EAT-10 (≥ 3, abnormal) .

\*eating assessment tool (EAT-10) 0 - 4 Rating Scale 0 = No problem

1. = Mild Problem
2. = Mild to moderate
3. = Moderate problem
4. = Severe problem

mean frequency (F0, Hz); Noise-to-Harmonic Ratio (NHR), jitter(%), and shimmer (%)

The maximal phonation time (sec) and s/z ratio were measured with circumferentially vented pneumotachography mask and differential transducers of the Aerophone system .

Vocal cord mobility, vocal cord closure (complete or incomplete), airway invasion during swallowing were inspected with fiber-optic endoscopy to show premature spillage, penetration-aspiration scale levels . The Yale pharyngeal residue severity rating scale for vallecula and pyriform sinus (0-4) (non-trace-mild-moderate-severe) and pyriform sinus (0-4) were also performed.

Forced vital capacity (FVC) (L), forced expiratory volume in 1 second (FEV1), bronchodilator test (BDT) (a positive response to BDT defined by the American Thoracic Society as an increase in FEV1 or FVC ≥ 12% and 200 ml), total lung capacity (TLC) (L), and alveolar volume (VA) using MasterScope (Jaeger, VIASYS healthcare GmbH, Höchberg, Germany), and diffusion capacity of the lung for carbon monoxide (DLCO) (%) using Vmax Autobox (SensorMedics, a subsidiary of VIASYS healthcare, California, USA).

The 6 minutes walking test (6MWT) was also performed to evaluate distance (meter) and O2 desaturation (differences of O2 saturation between pre- and post-tests) (defined as positive if O2 desaturation ≧ 4%).

Chang Gung Memorial Hospital

Consultant professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Kidney Diseases

Renal Insufficiency, Chronic

Renal Insufficiency

Urologic Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Bone Density Conservation Agents

Micronutrients

All Drugs and Chemicals

Vitamins

Vitamin D

Cholecalciferol

Calcifediol

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Calcium, Dietary

Trace Elements

Vitamin D3

Calciferol

CTAP101/Calcifediol Capsules 60 micrograms (mcg) once daily at bedtime, except on Days 1 and 29 when dosing will occur in the morning before breakfast

Immediate-release (IR) calcifediol/266 micrograms (mcg) capsule before breakfast on the mornings of Day 1 and Day 29

Cholecalciferol/Capsules 300,000 International Units (IU) (high-dose) before breakfast on the mornings of Day 1 and Day 29

Paricalcitol/Capsules 1 mcg plus cholecalciferol capsules 800 IU (low-dose) once daily in the morning before breakfast, except on Days 1 and29 when dosing will occur before breakfast

Calcifediol Oral Capsule

Calcifediol Oral Product

Paricalcitol Oral Capsule

An Open-Label, Repeated-Dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Oral CTAP101 Capsules, Immediate- Release (IR) Calcifediol, High-Dose Cholecalciferol, and Paricalcitol Plus Low-Dose Cholecalciferol in Patients with Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency

Repeated-dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of CTAP101, Immediate-release Calcifediol, High-dose Cholecalciferol, and Paricalcitol Plus Low-dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Chronic Kidney Disease 3-4 and Vitamin D Insufficiency

An Open-Label, Repeated-Dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Oral CTAP101 Capsules, Immediate- Release (IR) Calcifediol, High-Dose Cholecalciferol, and Paricalcitol Plus Low-Dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency

This study is descriptive and no primary or secondary efficacy endpoints are defined.

OPKO Health, Inc.

CTAP101/Calcifediol Capsules 60 micrograms (mcg) once daily at bedtime, except on Days 1 and 29 when dosing will occur in the morning before breakfast

Calcifediol Oral Capsule: Capsule, daily

CTAP101

Immediate-release (IR) calcifediol/266 micrograms (mcg) capsule before breakfast on the mornings of Day 1 and Day 29

Calcifediol Oral Product: Capsule, once a month

Immediate-release (IR) Calcifediol

Cholecalciferol/Capsules 300,000 International Units (IU) (high-dose) before breakfast on the mornings of Day 1 and Day 29

Cholecalciferol: Capsule, once a month

Paricalcitol/Capsules 1 mcg plus cholecalciferol capsules 800 IU (low-dose) once daily in the morning before breakfast, except on Days 1 and29 when dosing will occur before breakfast

Cholecalciferol: Capsule, once a month

Paricalcitol Oral Capsule: Capsule, daily

Paricalcitol

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

OPKO Health Inc

Grade 1 Mild

Grade 2 Moderate

Grade 3 Severe

Grade Potentially Life Threatening

Grade 5 Fatal

Incidence and Severity of Treatment-Emergent Adverse Events (TEAE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

Overall Study

Nutritional and Metabolic Diseases

Vitamin D Deficiency

Avitaminosis

Deficiency Diseases

Malnutrition

Nutrition Disorders

Hydroxycholecalciferols

CTAP101 Oral Capsules/Calcifediol, calcidiol, 25-hydroxyvitamin D3, 300mcg/weekly for 26 weeks

CTAP101 Oral Capsules/Calcifediol, calcidiol, 25-hydroxyvitamin D3, 600mcg/weekly for 26 weeks

CTAP101 Oral Capsules/Calcifediol, calcidiol, 25-hydroxyvitamin D3, 900mcg/weekly for 26 weeks

Placebo Oral Capsules/weekly for 26 weeks

Placebo oral capsule

Safety, Efficacy, PK and PD of CTAP101 (calcifediol) ER Capsules for SHPT in HD Patients VDI

A Multi-Center, Randomized, Two-Cohort Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of CTAP101 (calcifediol) Extended-Release Capsules to Treat Secondary Hyperparathyroidism in Subjects with Vitamin D Insufficiency and Chronic Kidney Disease Requiring Regular Hemodialysis.

Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI

A Multi-Center, Randomized, Two-Cohort Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of CTAP101 (Calcifediol) Extended-Release Capsules to Treat Secondary Hyperparathyroidism in Subjects With Vitamin D Insufficiency and Chronic Kidney Disease Requiring Regular Hemodialysis.

Change of at least 30% from pre-treatment baseline

Detailed information collected for each TEAE will include: AE number, a description of the event, start date, end date or ongoing as of date, outcome, therapy for event

Maximum serum concentration of Calcifediol

Parathyroid Hormone

1 capsule/day for 6 months. On Month 1 and Month 3 it can be increased up to 2 capsules/day or decreased down to 1 capsule/48 hours.

5 drops/day during 6 months. On Month 1 it can be increased up to 7 drops/day. If this occurs then, on Month 3, it can decreased to 5 drops/day or continue 7 drops/day until end of treatment.

Josep M Cruzado, Dr

To demonstrate the superiority of paricalcitol treatment at early renal post-transplantation (M6) in the control of iPTH (Intact parathyroid hormone) compared to the use of vitamin D nutritional supplements (calcifediol) in patients with renal transplantation.

The purpose of this study is to demonstrate the superiority of paricalcitol treatment at early renal post-transplantation (M6) in the control of iPTH (Intact parathyroid hormone) compared to the use of vitamin D nutritional supplements (calcifediol) in patients with renal transplantation.

Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Kidney Transplantation.

Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Renal Transplantation.

Percentage of patients with iPTH serum concentration \>110 pg/mL 6 month after transplant.

Change on iPTH serum concentration on each treatment group 6 month post transplantation.

Patients with at least one of the following events: acute rejection, acute rejection confirmed with biopsy and/or subclinic rejection and/or chronic damage.

Baseline speed of pulse wave was performed between 1 week and 1 month post transplant; next measure of speed of pulse wave performed at month 6 post transplant.

Percentage of patients with hypercalcemia (defined as serum calcium levels \> 10,3 mg/dl) on each treatment group at 6 months post transplantation.

HLAs corresponding to MHC (major histocompatibility complex) class I (A, B, and C) present peptides from inside the cell. HLAs corresponding to MHC class II (DP, DM, DO, DQ, and DR) present antigens from outside of the cell to T-lymphocytes.

AbbVie

Effice Servicios Para la Investigacion S.L.

Fundación Senefro

Paricalcitol oral capsules.

Paricalcitol: 1 capsule/day for 6 months. On Month 1 and Month 3 it can be increased up to 2 capsules/day or decreased down to 1 capsule/48 hours.

Calcifediol oral drops.

Calcifediol: 5 drops/day during 6 months. On Month 1 it can be increased up to 7 drops/day. If this occurs then, on Month 3, it can decreased to 5 drops/day or continue 7 drops/day until end of treatment.

48 patients were randomized to Calcifediol but 1 patient did not receive study medication because patient did not meet inclusion criteria. So total number of patients that were randomized and started Calcifediol was 47. Total randomized patients: 46+47=93

Dr. Josep M. Cruzado

Taking "per protocol" population, the percentage of patients with iPTH\> 110 pg / ml at 6 months post-transplant treated with Paricalcitol was statistically lower than in patients treated with Calcifediol

Percentage of Patients With iPTH Serum Concentration >110 pg/mL.

iPTH at month 6

iPTH at baseline

Change on iPTH Serum Concentration. Intention to Treat Analysis.

Percentage of Patients That Reach at Least a 30% iPTH Reduction at the End of the Study.

Percentage of Patients With iPTH Levels Between 70-110 pg/mL at the End of the Study. ITT.

Percentage of Patient With Presence of Calcifications on Protocol Renal Biopsies at 6 Months After Treatment in Each Treatment Group.

Patients That Suffered the Following Events: Acute Rejection, Acute Rejection Confirmed With Biopsy and/or Subclinic Rejection and/or Chronic Damage.

Baseline Osteocalcin

Month 6 Osteocalcin

This value was missing for some patients at month 6

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pulmonary Function, Voice and Swallowing Symptoms After Parathyroidectomy	NCT04267965	Secondary Hyper...	parathyroidecto...	20 Years - 80 Years	Chang Gung Memorial Hospital
Repeated-dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of CTAP101, Immediate-release Calcifediol, High-dose Cholecalciferol, and Paricalcitol Plus Low-dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Chronic Kidney Disease 3-4 and Vitamin D Insufficiency	NCT03588884	Secondary Hyper... Vitamin D Insuf... CKD Stage 3 CKD Stage 4	Calcifediol Ora... Calcifediol Ora... Cholecalciferol Paricalcitol Or...	18 Years -	OPKO Health, Inc.
Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI	NCT03602261	Secondary Hyper... Chronic Kidney ... Vitamin D Defic... Stage 5 Chronic...	Calcifediol Ora... Placebo oral ca...	18 Years -	OPKO Health, Inc.
Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI	NCT03602261	Secondary Hyper... Chronic Kidney ... Vitamin D Defic... Stage 5 Chronic...	Calcifediol Ora... Placebo oral ca...	18 Years -	OPKO Health, Inc.
Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Kidney Transplantation.	NCT01939977	Secondary Hyper...	Paricalcitol Calcifediol	18 Years -	Fundación Senefro

Spots Global Cancer Trial Database for secondary hyperparathyroidism due to renal causes