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Calcitonin

Calcitonin for Primary Hyperparathyroidism

Phase 4
Recruiting
Led By Joseph Sferra, MD
Research Sponsored by Joseph Sferra
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No contraindications to 99mTC-Sestamibi
No contraindications to treatment with calcitonin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

"This trial will include patients with confirmed primary hyperparathyroidism and inconclusive SPECT-CT scans from the past year. Patients will be given calcitonin to lower their calcium levels before undergoing

Who is the study for?
This trial is for patients with primary hyperparathyroidism who have high calcium levels and had a non-conclusive SPECT-CT scan in the last year. They should want surgery to treat their condition, be able to take calcitonin without health risks, and agree to a second SPECT-CT scan for research.
What is being tested?
The study tests if giving calcitonin, which lowers calcium levels, before re-imaging can improve the detection of parathyroid adenoma using SPECT-CT by enhancing sestamibi uptake/retention.
What are the potential side effects?
Potential side effects from calcitonin may include nausea, facial flushing, an upset stomach or allergic reactions like rash or itching. However, specific side effects will depend on individual patient responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am not allergic or sensitive to 99mTC-Sestamibi.
Select...
I can safely receive calcitonin treatment.
Select...
I have been diagnosed with primary hyperparathyroidism.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sensitivity of SPECT-CT
Secondary study objectives
Success Rate
Surgical Approach

Side effects data

From 2019 Phase 4 trial • 11 Patients • NCT03342001
9%
kidney stone
9%
nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment Group, Open Label

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment1 Intervention
All subjects in this arm will be treated with calcitonin 200IU 2x per day for 2 days, then 1x on day of SPECT-CT imaging
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Salmon calcitonin
FDA approved

Find a Location

Who is running the clinical trial?

Joseph SferraLead Sponsor
University of Toledo Health Science CampusOTHER
40 Previous Clinical Trials
16,367 Total Patients Enrolled
ProMedica Health SystemLead Sponsor
13 Previous Clinical Trials
723 Total Patients Enrolled
~8 spots leftby Jun 2026
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