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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

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

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.

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.

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:

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My family has a history of hearing loss not due to OI or work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pure Tone Averages

Secondary study objectives

Adolescent Outcomes Questionnaire Score

DEXA Bone Mineral Density

DEXA Z-score

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 9Eligibility criteria met