Phase 4 Hearing Loss Trial, Recruiting (NCT04152551)

Phase 4 Hearing Loss Trial, Recruiting NCT04152551 Sponsor: Hospital for Special Surgery, New York Condition: Hearing Loss

Printed from Voxsanity (voxsanity.com.au) — NCT04152551 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Hearing Loss

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

Adult Treatment Group:

You have been diagnosed with Osteogenesis Imperfecta (OI) Type I (a condition affecting bone strength)
You have been diagnosed with at least mild hearing loss (confirmed by a hearing test)
You are 18 years of age or older
Your Vitamin D level is above 30 (as measured by a blood test)

Adult Control Group:

You have been diagnosed with Osteogenesis Imperfecta (OI) Type I

Children's Group (currently receiving bone-strengthening medication):

You have been diagnosed with Osteogenesis Imperfecta (OI) in any form
You are between 6 and 17 years old
You are currently receiving bisphosphonate treatment (a type of medication used to strengthen bones) as part of your regular care

Children's Group (not receiving bone-strengthening medication):

You have been diagnosed with Osteogenesis Imperfecta (OI) in any form
You are between 6 and 17 years old
You are not currently receiving bisphosphonate medication and do not plan to take it during the study

Who may not be able to join:

You have a family history of hearing loss that is not related to OI or caused by working in a loud environment
You are currently pregnant

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 27 July 2026

Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Cathleen Raggio, MD, Hospital for Special Surgery, New York

Phone: (212)774-2355

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT04152551

Sponsor: Hospital for Special Surgery, New York

Phase: Phase 4

Status: Recruiting

Condition: Hearing Loss

Trial contact: (212)774-2355

More information: https://clinicaltrials.gov/study/NCT04152551

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Adult Treatment Group:

You have been diagnosed with Osteogenesis Imperfecta (OI) Type I (a condition affecting bone strength)
You have been diagnosed with at least mild hearing loss (confirmed by a hearing test)
You are 18 years of age or older
Your Vitamin D level is above 30 (as measured by a blood test)

Adult Control Group:

You have been diagnosed with Osteogenesis Imperfecta (OI) Type I

Children's Group (currently receiving bone-strengthening medication):

You have been diagnosed with Osteogenesis Imperfecta (OI) in any form
You are between 6 and 17 years old
You are currently receiving bisphosphonate treatment (a type of medication used to strengthen bones) as part of your regular care

Children's Group (not receiving bone-strengthening medication):

You have been diagnosed with Osteogenesis Imperfecta (OI) in any form
You are between 6 and 17 years old
You are not currently receiving bisphosphonate medication and do not plan to take it during the study

Who may not be able to join:

You have a family history of hearing loss that is not related to OI or caused by working in a loud environment
You are currently pregnant

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 27 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Phase 4

Sponsor

Hospital for Special Surgery, New York

Registry

ClinicalTrials.gov

Start date

2 November 2019

Est. completion

1 January 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Pure Tone Averages

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov