Efficacy and Safety of Ultrasonic Ablation to Treat Secondary Hyperparathyroidism in Chronic Kidney Disease Patients

• Sponsor: Dongliang Zhang, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT01640184
• Collaborator: Beijing Municipal Science & Technology Commission (Other)
• Enrollment: 79
• Locations: 2
• Arms: 3
• Duration (Months): 27
• Patients Per Site: 39.5
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

It is difficulty for the treatment of secondary hyperparathyroidism in the chronic kidney disease (CKD) patients who had not succeeded medical therapy and could not get parathyroidectomy. The investigators suppose that ultrasonic ablation may be a valuable alternative treatment that help control secondary hyperparathyroidism in CKD patients presenting with enlarged parathyroid gland(s) visible at ultrasonography.

Condition or Disease	Intervention/Treatment	Phase
Hyperparathyroidism; Disorders of Parathyroid Gland	Procedure: Parathyroidectomy; Drug: Active vitamin D; Procedure: Ultrasonic ablation	N/A

Detailed Description

Secondary hyperparathyroidism (sHPT) is common in patients with chronic kidney disease (CKD), including those who are undergoing long-term dialysis treatments. sHPT is damaged for bone system, blood system, cardiovascular system, and so on. The treatment of the sHPT of CKD's patient includes dietary phosphate restriction, the use of medicines, and parathyroidectomy. In the mainland of China, there are not certain useful medicines to treat sHPT, including the derivatives of vitamin D, calcimimetic agent, non calcium aluminum phosphate binders. Furthermore, medical therapy is not always successful in achieving adequate control of sHPT. Oral medications have efficacy limitations as well as side-effects. Otherwise, surgery treatment can only be used for the patients with enlarged parathyroid gland(s). The patients may suffer from the injury of operation, hypoparathyroidism, or recurrence of hyperparathyroidism after parathyroidectomy.

Then ultrasonic ablation may become a valuable alternative treatment that help control sHPT in selected patients presenting with enlarged parathyroid gland(s) visible at ultrasonography,.

Study Design

• Study Type: Interventional
• Actual Enrollment: 79 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study of the Efficacy and Safety on the Ultrasonic Ablation Treatment for Secondary Hyperthyroidism in Chronic Kidney Disease Patients.
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Active vitamin D Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in Kidney Developement Improvement Global Outcomes (KDIGO) guidelines.	Drug: Active vitamin D; CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines.; Other Names: Oral medicine
Experimental: Ultrasonic ablation Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.	Procedure: Ultrasonic ablation; CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively.; Other Names: Ultrasonic intervention
Active Comparator: Parathyroidectomy Patients in parathyroidectomy group will be treated by parathyroid surgery.	Procedure: Parathyroidectomy; sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.; Other Names: Parathyroid surgery

Outcome Measures

Primary Outcome Measures

1. Rate of Achieving the Target on Blood Intact Parathyroid Hormone Level According to Kidney Development Improvement Global Outcome (KDIGO) Guidelines. [12 months]

   The blood levels of intact parathyroid hormone (iPTH) will be detected every 3 months for stable patients. The blood test will be more frequent, at least once per-month, after the ultrasonic ablation treatment, surgery, or during the impulse therapy of active vitamin D with large doses.

Secondary Outcome Measures

1. Incidence of Injury on the Recurrent Laryngeal Nerve (RLN). [12 months]

   Comparison of the incidence of RLN injury between ultrasonic ablation group and parathyroidectomy group.

2. Changes of the Blood Levels on Calcium During 12 Months. [Baseline and 12 months]

   The blood levels of calcium will be detected at least once every 3 months and will be compared to the baseline levels.

3. Changes of Blood Levels on Phosphorus During 12 Months. [Baseline and 12 months]

   The blood levels of phosphorus will be detected at least once every 3 months and will be compared to the baseline levels.

4. Changes of Blood Levels on iPTH During 12 Months. [Baseline and 12 months]

   The blood levels of iPTH will be detected at least once every 3 months and will be compared to the baseline levels.

5. Changes of Blood Levels on Bone Specific Alkaline Phosphatase. [Baseline and 12 months]

   The blood levels of bone specific alkaline phosphatase will be detected at least once every 3 months and will be compared to the baseline levels.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with age between 18 - 75 years.

• Patients with parathyroid nodular or diffuse hyperplasia demonstrated on ultrasound imaging or radioisotope scan.

• CKD patients in stage 5, with elevated intact parathyroid hormone (iPTH) levels > 800pg/mL.

• CKD patients have been followed up more than 6 months.

Exclusion Criteria:

• Primary or Tertiary Hyperparathyroidism (hyperparathyroidism after kidney transplantation).

• Patient who underwent total parathyroidectomy and without enlarged parathyroid gland(s).

• Known history of parathyroid or other neoplasias in the neck region.

• History of neck irradiation.

• Major surgery of neck in the last 3 months or other major surgery projected in the subsequent 4 months.

• Pregnant or lactating woman.

• Patient receiving drugs such as phenobarbital, phenytoin, rifampicin, sucralfate, steroids, flecainide, thioridazine, or most tricyclic antidepressants which could affect vitamin D metabolism.

• Treatment with vitamin D derivatives, cinacalcet or other calcimimetics within the past 6 months.

• Patients who are currently participating in another clinical trial.

• The expected live time is less than 1 year.

• Patients suffered from acute myocardial infraction, acute congestive heart failure, or stroke in last 6 months.

• Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Chao-Yang Hospital	Beijing	Beijing	China	100020
2	Beijing Friendship Hospital	Beijing	Beijing	China	100050

Sponsors and Collaborators

• Dongliang Zhang, MD
• Beijing Municipal Science & Technology Commission

Investigators

• Principal Investigator: Linxue Qian, Doctor, Beijing Friendship Hospital
• Study Director: Dongliang Zhang, Doctor, Beijing Friendship Hospital
• Study Chair: Wenhu Liu, Doctor, Beijing Friendship Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dongliang Zhang, MD, associate professor, Capital Medical University
• ClinicalTrials.gov Identifier: NCT01640184
• Other Study ID Numbers: 2012-079; Z121107001012138; 2001-2002-02
• First Posted: Jul 13, 2012
• Last Update Posted: Oct 17, 2016
• Last Verified: Aug 1, 2016

• Keywords provided by Dongliang Zhang, MD, associate professor, Capital Medical University: hyperparathyroidism; vitamin D; ultrasonic ablation; surgery
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Parathyroid Diseases; Vitamin D

Study Results

Participant Flow

Arm/Group Title	Active Vitamin D	Ultrasonic Ablation	Parathyroidectomy
Arm/Group Description	Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines. Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines.	Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively.	Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.
Period Title: Overall Study
STARTED	34	23	22
COMPLETED	26	21	20
NOT COMPLETED	8	2	2

Baseline Characteristics

Arm/Group Title	Active Vitamin D	Ultrasonic Ablation	Parathyroidectomy	Total
Arm/Group Description	Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines. Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines.	Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively.	Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.	Total of all reporting groups
Overall Participants	34	23	22	79
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	56.3	52.0	55.2	55.3
Sex: Female, Male (Count of Participants)
Female	20 58.8%	12 52.2%	13 59.1%	45 57%
Male	14 41.2%	11 47.8%	9 40.9%	34 43%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	34 100%	23 100%	22 100%	79 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
China	34 100%	23 100%	22 100%	79 100%
Ca-baseline (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	2.31 (0.27)	2.43 (0.30)	2.53 (0.23)	2.41 (0.30)
P-baseline (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	1.95 (0.49)	2.14 (0.66)	2.12 (0.45)	2.10 (0.51)
iPTH-baseline (ng/ml) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ng/ml]	239.84 (299.01)	1550.6 (521.7)	1779.9 (514.1)	1201.8 (498.7)
BALP-baseline (microgram/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [microgram/L]	17.31 (6.38)	18.84 (17.94)	19.27 (14.87)	17.98 (13.32)

Outcome Measures

1. Primary Outcome

Title	Rate of Achieving the Target on Blood Intact Parathyroid Hormone Level According to Kidney Development Improvement Global Outcome (KDIGO) Guidelines.
Description	The blood levels of intact parathyroid hormone (iPTH) will be detected every 3 months for stable patients. The blood test will be more frequent, at least once per-month, after the ultrasonic ablation treatment, surgery, or during the impulse therapy of active vitamin D with large doses.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Number of participants analyzed is the number of patients completed study.

Arm/Group Title	Active Vitamin D	Ultrasonic Ablation	Parathyroidectomy
Arm/Group Description	Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines. Active vitamin D: chronic kidney disease (CKD) patients suffered from secondary hyperparathyroidism (sHPT) with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines.	Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively.	Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.
Measure Participants	26	21	20
Number [percentage of participants]	30.8 90.6%	57.1 248.3%	90.0 409.1%

2. Secondary Outcome

Title	Incidence of Injury on the Recurrent Laryngeal Nerve (RLN).
Description	Comparison of the incidence of RLN injury between ultrasonic ablation group and parathyroidectomy group.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ultrasonic Ablation	Parathyroidectomy
Arm/Group Description	Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively.	Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.
Measure Participants	21	20
Number [participants]	0 0%	2 8.7%

3. Secondary Outcome

Title	Changes of the Blood Levels on Calcium During 12 Months.
Description	The blood levels of calcium will be detected at least once every 3 months and will be compared to the baseline levels.
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Vitamin D	Ultrasonic Ablation	Parathyroidectomy
Arm/Group Description	Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines. Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines.	Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively.	Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.
Measure Participants	26	21	20
Mean (Standard Deviation) [mmol/L]	2.34 (0.22)	1.84 (0.21)	1.93 (0.26)

4. Secondary Outcome

Title	Changes of Blood Levels on Phosphorus During 12 Months.
Description	The blood levels of phosphorus will be detected at least once every 3 months and will be compared to the baseline levels.
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Vitamin D	Ultrasonic Ablation	Parathyroidectomy
Arm/Group Description	Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines. Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines.	Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively.	Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.
Measure Participants	26	21	20
Mean (Standard Deviation) [mmol/L]	1.91 (0.41)	1.51 (0.29)	1.29 (0.33)

5. Secondary Outcome

Title	Changes of Blood Levels on iPTH During 12 Months.
Description	The blood levels of iPTH will be detected at least once every 3 months and will be compared to the baseline levels.
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Vitamin D	Ultrasonic Ablation	Parathyroidectomy
Arm/Group Description	Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines. Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines.	Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively.	Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.
Measure Participants	26	21	20
Mean (Standard Deviation) [ng/ml]	252.2 (172.0)	372.1 (253.6)	246.5 (228.4)

6. Secondary Outcome

Title	Changes of Blood Levels on Bone Specific Alkaline Phosphatase.
Description	The blood levels of bone specific alkaline phosphatase will be detected at least once every 3 months and will be compared to the baseline levels.
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Vitamin D	Ultrasonic Ablation	Parathyroidectomy
Arm/Group Description	Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines. Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines.	Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively.	Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.
Measure Participants	26	21	20
Mean (Standard Deviation) [microgram/L]	13.60 (5.86)	19.48 (17.33)	19.20 (17.95)

Adverse Events

Arm/Group Title	Active Vitamin D		Ultrasonic Ablation		Parathyroidectomy
Arm/Group Description	Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines. Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines.		Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively.		Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.
All Cause Mortality
	Active Vitamin D		Ultrasonic Ablation		Parathyroidectomy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Active Vitamin D		Ultrasonic Ablation		Parathyroidectomy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/34 (2.9%)		0/23 (0%)		0/22 (0%)
Cardiac disorders
Death	1/34 (2.9%)	1	0/23 (0%)	0	0/22 (0%)	0
Other (Not Including Serious) Adverse Events
	Active Vitamin D		Ultrasonic Ablation		Parathyroidectomy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		5/23 (21.7%)		15/22 (68.2%)
Injury, poisoning and procedural complications
Hypocalcemia	0/34 (0%)	0	2/23 (8.7%)	2	15/22 (68.2%)	15
Hoarse	0/34 (0%)	0	5/23 (21.7%)	5	8/22 (36.4%)	8

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.