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NCT04152551 · ClinicalTrials.gov registry record · Phase 4
Effects of Bisphosphonates on OI-Related Hearing Loss
A Phase 4 study of Osteogenesis Imperfecta, sponsored by Hospital for Special Surgery, New York.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT04152551 is a Phase 4 study of Osteogenesis Imperfecta that is actively recruiting participants, run by Hospital for Special Surgery, New York. The registered enrollment target is 100 participants, below the 154-participant average among 13 other Osteogenesis Imperfecta trials with a reported enrollment target (35% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04152551, a Phase 4 study of Osteogenesis Imperfecta, is actively recruiting participants, sponsored by Hospital for Special Surgery, New York.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
Osteogenesis Imperfecta-related hearing loss usually occurs in individuals with mild (type I) OI and is much earlier in onset than age-related hearing loss, with the majority of individuals experiencing some minor hearing loss in their 20s. Bisphosphonates have been successfully used to treat otosclerosis, a common cause of hearing loss similar to OI-related hearing loss. As many individuals with OI-related hearing loss also present with otosclerosis and because of their mechanistic similarities, the investigators propose studying the effects of bisphosphonate treatment on individuals diagnosed with both OI type I and hearing loss, thereby determining its effectiveness as a potential treatment for hearing loss. The investigators will enroll 50 individuals diagnosed with type I OI and age 18-100. 25 adults will be enrolled into the treatment arm and receive bisphosphonate treatment (must have at least mild hearing loss), while 25 adults will be enrolled into the control arm. The investigators will enroll 25 children (6-17 years of age) diagnosed with OI who are currently receiving bisphosphonate treatment as part of their care for orthopedic symptoms. The investigators will also observe 25 children (6-17 years of age) diagnosed with OI who are NOT currently receiving bisphosphonate treatment. The study duration is 63 months (approximately 5 years). Enrollment is anticipated to begin in November 2019.
Conditions Studied
Interventions
- DRUG Risedronate Oral Tablet
Study Locations (1)
New York
- Hospital for Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2019-11-02 |
| Est. Completion | 2026-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04152551
The ClinicalTrials.gov registry entry for NCT04152551 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 154-participant average among 13 other Osteogenesis Imperfecta trials with a reported enrollment target (35% lower). The listed sponsor is Hospital for Special Surgery, New York, which has 194 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Osteogenesis Imperfecta appearing as the primary indexed condition, and to 1 intervention - of which Risedronate Oral Tablet is the first listed.
NCT04152551 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT04152551 about?
NCT04152551 is a clinical study titled "Effects of Bisphosphonates on OI-Related Hearing Loss". Osteogenesis Imperfecta-related hearing loss usually occurs in individuals with mild (type I) OI and is much earlier in onset than age-related hearing loss, with the majority of individuals experiencing some minor hearing loss in their 20s. Bisphosphonates have been successfully used to treat otoscl...
What is the current status of trial NCT04152551?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2019-11-02. Estimated completion is 2026-01.
What conditions does trial NCT04152551 study?
This clinical trial studies the following conditions: Osteogenesis Imperfecta.
What interventions are being tested in trial NCT04152551?
The interventions under investigation include: Risedronate Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT04152551?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04152551 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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