Osteogenesis imperfecta: clinical diagnosis, nomenclature and severity assessment.
F S Van Dijk, D O Sillence
https://pubmed.ncbi.nlm.nih.gov/24715559Actively Recruiting
Phase 4
Age: 6Years - 100Years
All Genders
Healthy Volunteers
ID04152551
Effects of Bisphosphonates on Osteogenesis Imperfecta-Related Hearing Loss: A Pilot Study
Led by Hospital for Special Surgery, New York · Updated on 2026-04-28
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Hospital for Special Surgery, New York
Lead Sponsor
T
The New York Community Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of bisphosphonate treatment on hearing loss in individuals with Osteogenesis Imperfecta (OI), specifically type I, which often causes early hearing loss distinct from typical age-related hearing loss. This trial aims to determine whether bisphosphonates can be a potential treatment for hearing loss in people diagnosed with OI type I and mild hearing loss, building on bisphosphonates' success in treating otosclerosis, a similar condition. The study is a Phase 4 pilot study sponsored by the Hospital for Special Surgery, New York.
CONDITIONS
Brief Title
Effects of Bisphosphonates on OI-Related Hearing Loss
Who Can Participate
Age: 6Years - 100Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older with type I Osteogenesis Imperfecta and at least mild hearing loss (greater than 20 dB pure tone average) confirmed by audiogram
- Adults 18 years or older with type I Osteogenesis Imperfecta (control group)
- Children aged 6 to 17 years with Osteogenesis Imperfecta currently receiving bisphosphonate treatment as standard care
- Children aged 6 to 17 years with Osteogenesis Imperfecta not receiving bisphosphonate treatment and will not receive it during the study
You will not qualify if you...
- Family history of hearing loss not related to Osteogenesis Imperfecta or occupational hearing loss
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 60 months
Adult participants with type I Osteogenesis Imperfecta and hearing loss receive oral bisphosphonate treatment while hearing, quality of life, and bone density are monitored.
Regular visits at baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months
Monitoring
Duration - Up to 60 months
Children and adult participants not receiving investigational treatment are observed for changes in hearing, quality of life, and bone density during routine care.
Assessments at baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months
Trial Site Locations
Total: 1 location
1
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
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Research Team
S
Su Htwe
E
Erin Carter, MS, CGC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
4
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Published Research Related To This Trial
Hearing loss in osteogenesis imperfecta: characteristics and treatment considerations.
Joseph P Pillion, David Vernick, Jay Shapiro
https://pubmed.ncbi.nlm.nih.gov/22567374Osteogenesis imperfecta: an expanding panorama of variants.
D Sillence
https://pubmed.ncbi.nlm.nih.gov/7285446Audiometric, surgical, and genetic findings in 15 ears of patients with osteogenesis imperfecta.
Freya K R Swinnen, Els M R De Leenheer, Paul J Coucke...
https://pubmed.ncbi.nlm.nih.gov/19358256Histopathology of the temporal bone in osteogenesis imperfecta congenita: a report of 5 cases.
G Berger, M Hawke, A Johnson...
https://pubmed.ncbi.nlm.nih.gov/3918222Stapedotomy in osteogenesis imperfecta: a prospective study of 32 consecutive cases.
Robert Vincent, Inge Wegner, Inge Stegeman...
https://pubmed.ncbi.nlm.nih.gov/24751750Prevention of osteocyte and osteoblast apoptosis by bisphosphonates and calcitonin.
L I Plotkin, R S Weinstein, A M Parfitt...
https://pubmed.ncbi.nlm.nih.gov/10562298Molecular mechanisms of action of bisphosphonates.
M J Rogers, J C Frith, S P Luckman...
https://pubmed.ncbi.nlm.nih.gov/10321934Bisphosphonates: mechanism of action and role in clinical practice.
Matthew T Drake, Bart L Clarke, Suneep Khosla
https://pubmed.ncbi.nlm.nih.gov/18775204Resorption of auditory ossicles and hearing loss in mice lacking osteoprotegerin.
Sho Kanzaki, Masako Ito, Yasunari Takada...
https://pubmed.ncbi.nlm.nih.gov/16564235