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Effects of Bisphosphonates on OI-Related Hearing Loss

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Primary and study completion dates: Jan 2026 to Jan 2027v10
  2. Primary and study completion dates: Nov 2025 to Jan 2026v9
  3. Primary and study completion dates: Nov 2024 to Nov 2025
    • Site contact updated
    v8
  4. 2 versions Re-verified since Apr 5, 2023, no change to tracked fieldsv6-v7
  5. Eligibility criteria expanded, about 10 words
    • Site contact updated
    • Collaborators revised (3)
    • Study arms: 3 to 4
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Re-verified, no change to tracked fieldsv4
  2. Site contact updatedv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 2019 to Nov 2, 2019
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04152551
Lead Sponsor Hospital for Special Surgery, New York
Collaborators: The New York Community Trust, East River Medical Imaging, Northwell Health
Conditions
(from sponsor)		 Osteogenesis Imperfecta
Related terms Brittle Bone Disorder, Hearing Loss, Mucopolysaccharidosis IV, Osteogenesis Imperfecta
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov