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Bisphosphonate

Bisphosphonates for Hearing Loss

Phase 4
Recruiting
Led By Cathleen Raggio, MD
Research Sponsored by Hospital for Special Surgery, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Child Observational No Treatment Arm: Age 6-17 years
Adult Treatment Arm: Diagnosis of at least mild hearing loss (>20dB pure tone average) by audiogram testing
Must not have
ALL ARMS: Family history of hearing-loss (not related to OI or occupational hearing loss)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Awards & highlights

Summary

This trial is studying if bisphosphonate treatment can help improve hearing loss in people with OI type I.

Who is the study for?
This trial is for individuals with type I Osteogenesis Imperfecta (OI) and hearing loss. Adults aged 18+ with mild hearing loss and children aged 6-17, whether currently on bisphosphonates or not, can join. Participants must have a Vitamin D level >30. Those with family history of non-OI related hearing loss or pregnant individuals cannot participate.Check my eligibility
What is being tested?
The study tests the effects of Risedronate Oral Tablet, a bisphosphonate, on OI-related hearing loss in adults and observes its use in children already receiving it for orthopedic symptoms. It's a comparison between treated adults/children and untreated controls over approximately 5 years.See study design
What are the potential side effects?
While specific side effects are not listed here, bisphosphonates like Risedronate may commonly cause digestive issues, muscle or joint pain, and sometimes more serious conditions such as jaw bone problems or unusual thigh bone fractures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My child is between 6 and 17 years old.
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I have been diagnosed with mild hearing loss.
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I am currently receiving bisphosphonate treatment.
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I am 18 years old or older.
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I have been diagnosed with Osteogenesis Imperfecta type I.
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I have been diagnosed with Osteogenesis Imperfecta type I.
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My child has been diagnosed with Osteogenesis Imperfecta (OI).
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My child has been diagnosed with Osteogenesis Imperfecta.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My family has a history of hearing loss not due to OI or work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pure Tone Averages
Secondary outcome measures
Adolescent Outcomes Questionnaire Score
DEXA Bone Mineral Density
DEXA Z-score
+7 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Adult Treatment ArmExperimental Treatment1 Intervention
Intervention treatment arm. Adults (18+ years) with type 1 OI. Must have at least mild hearing loss. Will receive Risedronate (35mg, 0-2x/week as clinically indicated) for duration of study. Changes in hearing, quality of life, and bone density will be monitored.
Group II: Adult Control ArmActive Control1 Intervention
Observational arm. Adults (18+ years) with type 1 OI. Changes in hearing, quality of life, and bone density will be monitored.
Group III: Child (Control Arm)Active Control1 Intervention
Observational arm. Children (6-17 years) with any type of OI who are not receiving bisphosphonate treatment. Changes in hearing, quality of life, and bone density will be observed for the duration of the study.
Group IV: Child (Bisphosphonate Arm)Active Control1 Intervention
Observational (no investigational intervention) arm. Children (6-17 years) with any type of OI who are already receiving bisphosphonate treatment as standard of care treatment for orthopedic symptoms. Changes in hearing, quality of life, and bone density will be observed for the duration of the study.

Find a Location

Who is running the clinical trial?

Northwell HealthOTHER
461 Previous Clinical Trials
471,035 Total Patients Enrolled
Hospital for Special Surgery, New YorkLead Sponsor
246 Previous Clinical Trials
59,504 Total Patients Enrolled
2 Trials studying Osteogenesis Imperfecta
1,075 Patients Enrolled for Osteogenesis Imperfecta
East River Medical ImagingUNKNOWN

Media Library

Risedronate Oral Tablet (Bisphosphonate) Clinical Trial Eligibility Overview. Trial Name: NCT04152551 — Phase 4
Osteogenesis Imperfecta Research Study Groups: Adult Treatment Arm, Adult Control Arm, Child (Control Arm), Child (Bisphosphonate Arm)
Osteogenesis Imperfecta Clinical Trial 2023: Risedronate Oral Tablet Highlights & Side Effects. Trial Name: NCT04152551 — Phase 4
Risedronate Oral Tablet (Bisphosphonate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04152551 — Phase 4
~5 spots leftby Nov 2024
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