Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 4 study of Osteogenesis Imperfecta, sponsored by Hospital for Special Surgery, New York.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Average hearing thresholds at 250, 500, 1000, 2000, 3000, 4000, 8000 Hertz
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 |
What NCT04152551 shows while recruiting
NCT04152551 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 154-participant average among 13 other Osteogenesis Imperfecta trials with a reported enrollment target (35% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Osteogenesis Imperfecta
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04152551's enrollment target sits among peer trials
100 6th of 13 higher than 8 of 13 other Osteogenesis Imperfecta trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteogenesis Imperfecta 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
RECRUITING · Phase 3
-
BBD Longitudinal Study of Osteogenesis Imperfecta
RECRUITING
-
Setrusumab vs Placebo for Osteogenesis Imperfecta
ACTIVE NOT RECRUITING · Phase 2
-
Urinary Biomarkers of OI Pathobiology
ACTIVE NOT RECRUITING
-
Clear Aligners for the Treatment of Dental Malocclusion in OI
ACTIVE NOT RECRUITING · NA
-
Cardiopulmonary Outcomes in Osteogenesis Imperfecta: BBD7708
ACTIVE NOT RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01048281 · 100 participants
Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma
- NCT01161199 · 100 participants
The Use of Leukapheresis to Support HIV Pathogenesis Studies
- NCT01327690 · 100 participants · Early Phase 1
Mental Health in Veterans and Families After Group Therapies
- NCT01730781 · 100 participants
Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI