Trial Outcomes & Findings for Hypothyroidism Treated With Calcitonin (NCT NCT03342001)

NCT ID: NCT03342001

Last Updated: 2022-02-21

Results Overview

questionnaire to assess quality of life, 40 questions, 1-10 scale with 10 indicating more severe symptoms. Total 400 points, primary assessment was change in score after 6 weeks.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 11 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2022-02-21

Participant Flow

Participant milestones

Measure	Treatment Group, Open Label calcitonin nasal spray, 200 mcg daily Calcitonin: calcitonin nasal spray
Overall Study STARTED	11
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Treatment Group, Open Label calcitonin nasal spray, 200 mcg daily Calcitonin: calcitonin nasal spray
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

Hypothyroidism Treated With Calcitonin

Baseline characteristics by cohort

Measure	Calcitonin n=11 Participants People with hypothyroidism
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	63 years STANDARD_DEVIATION 22 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: participants completing trial

questionnaire to assess quality of life, 40 questions, 1-10 scale with 10 indicating more severe symptoms. Total 400 points, primary assessment was change in score after 6 weeks.

Outcome measures

Measure	Treatment Group, Open Label n=9 Participants calcitonin nasal spray, 200 mcg daily Calcitonin: calcitonin nasal spray
Modified City of Hope Quality of Life Questionnaire for Patients With Thyroid Disease	-36.33 score on a scale Standard Deviation 39.41

Adverse Events

Treatment Group, Open Label

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment Group, Open Label n=11 participants at risk calcitonin nasal spray, 200 mcg daily Calcitonin: calcitonin nasal spray
Gastrointestinal disorders nausea	9.1% 1/11 • Number of events 1 • Only during trial 6 weeks per participant Low risk trial and no reasonable expectation of serious adverse event or mortality
Renal and urinary disorders kidney stone	9.1% 1/11 • Number of events 1 • Only during trial 6 weeks per participant Low risk trial and no reasonable expectation of serious adverse event or mortality

Additional Information

Dr. Kashif Munir

University of Maryland School of Medicine

Phone: 443-682-6873

Email: kmunir@som.umaryland.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place