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NCT03324880 · ClinicalTrials.gov registry record · Phase 4
A Study to Learn if Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Can Improve Symptoms and Metabolic Control in Adults With Hypoparathyroidism (BALANCE)
A Phase 4 study of Hypoparathyroidism, sponsored by Shire.
- Completed
- Registry status
- Phase 4
- Development phase
- 93
- Enrollment target
- 20
- Study locations
NCT03324880: Completed Phase 4 study of Hypoparathyroidism, sponsored by Shire.
NCT03324880 is a Phase 4 study of Hypoparathyroidism that has completed, run by Shire. The registered enrollment target is 93 participants, below the 190-participant average among 10 other Hypoparathyroidism trials with a reported enrollment target (51% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03324880, a Phase 4 study of Hypoparathyroidism, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 93 participants
- Enrollment target
- 20
- Study locations
Study Summary
Recombinant human parathyroid hormone, also known as if rhPTH(1-84), is a medicine to treat people with Hypothyroidism. The main aim of this study is to learn if rhPTH(1-84) can improve symptoms in adults with hypoparathyroidism. In this study, participants will receive 1 of 2 treatments: rhPTH(1-84) or a placebo. A placebo looks like the medicine being studied but does not have medicine in it. In this study, the placebo will be a standard treatment which is either active Vitamin D, or active Vitamin D with calcium. Active Vitamin D is a form of vitamin D that has a faster effect on the body. These treatments will be given as a daily injection just under the skin. Participants will not know which treatment they received, nor will their study doctors. This is to help make sure the results are more reliable. All participants will also take active vitamin D and calcium supplements during treatment. Participants will record their symptoms in a tool called the hypoparathyroidism symptom diary. This tool is used to assess symptoms and their impact and will give an overall score for each participant. The study doctors will also check for side effects from the study treatments. After treatment, researchers will check if there is any difference in the diary scores between the 2 treatment groups. A difference in score means there is a difference in symptoms and their impact. From this, researchers will learn if symptoms have improved for participants treated with rhPTH(1-84) compared with those treated with placebo.
Primary Outcome
The HypoPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness or depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4; for items 10-13, it ranges from Not at all=0 to Very much=2. An item score was computed by taking the average of the daily item response over the 14-day period immediately before the visit. If data were not avai
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL rhPTH (1-84)
Study Locations (20)
Other
- CHU de Quebec-Universite Laval - Québec
- Eastern Health - Health Sciences Center- General Hospital - St. John's
- Odense Universitetshospital - Odense C
- CHU Angers - Angers
- Hopital Jean Minjoz - Besançon
- CHU Bicêtre - Le Kremlin-Bicêtre
- CHRU Lille - Lille
Illinois
- University of Chicago - Chicago
Michigan
- Michigan Bone and Mineral Clinic - Detroit
Minnesota
- Mayo Clinic - PPDS - Rochester
North Carolina
- Physicians East PA - Greenville
Ohio
- Ohio State University Wexner Medical Center - Columbus
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Oost-Vlaanderen
- UZ Gent - Ghent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2018-01-24 |
| Est. Completion | 2022-05-19 |
| Phase | Phase 4 |
What the finished NCT03324880 record still lists
NCT03324880 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 190-participant average among 10 other Hypoparathyroidism trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Hypoparathyroidism appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03324880 names 20 study sites across 14 states, led by Other, Illinois, Michigan.
Frequently Asked Questions
What is clinical trial NCT03324880 about?
NCT03324880 is a clinical study titled "A Study to Learn if Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Can Improve Symptoms and Metabolic Control in Adults With Hypoparathyroidism (BALANCE)". Recombinant human parathyroid hormone, also known as if rhPTH(1-84), is a medicine to treat people with Hypothyroidism. The main aim of this study is to learn if rhPTH(1-84) can improve symptoms in adults with hypoparathyroidism. In this study, participants will receive 1 of 2 treatments: rhPTH(1-8...
What is the current status of trial NCT03324880?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 93 participants. The study started on 2018-01-24. Estimated completion is 2022-05-19.
What conditions does trial NCT03324880 study?
This clinical trial studies the following conditions: Hypoparathyroidism.
What interventions are being tested in trial NCT03324880?
The interventions under investigation include: Placebo (BIOLOGICAL), rhPTH (1-84) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03324880?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03324880 being conducted?
This trial has 20 study locations across Illinois, Michigan, Minnesota, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03324880's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypoparathyroidism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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