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Bisphosphonates for Hearing Loss
Study Summary
This trial is studying if bisphosphonate treatment can help improve hearing loss in people with OI type I.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- My family has a history of hearing loss not due to OI or work.My child is between 6 and 17 years old.I am between 6 and 17 years old.I have been diagnosed with mild hearing loss.I am currently receiving bisphosphonate treatment.Your vitamin D level is higher than 30.I am 18 years old or older.I have been diagnosed with Osteogenesis Imperfecta type I.I have been diagnosed with Osteogenesis Imperfecta type I.My child has been diagnosed with Osteogenesis Imperfecta (OI).My child has been diagnosed with Osteogenesis Imperfecta.My child is not and will not be on bisphosphonate treatment during the study.
- Group 1: Adult Treatment Arm
- Group 2: Adult Control Arm
- Group 3: Child (Control Arm)
- Group 4: Child (Bisphosphonate Arm)
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What indications has Risedronate Oral Tablet been demonstrated to ameliorate?
"The conventional treatment for osteoporosis is typically Risedronate Oral Tablet, which can also be beneficial to those with malignant neoplasms, postmenopausal women, and bone-related difficulties."
Does this research project still accept participants?
"Affirmative. As evidenced by clinicaltrials.gov, this research is currently in its recruitment phase after being first published on November 2nd 2019 and last updated March 31st 2022. To be able to reach the study's goal of 100 participants, only one medical site will need to enrol them all."
Have there been any additional investigations on the effectiveness of Risedronate Oral Tablet?
"Presently, there are 3 research initiatives centered around Risedronate Oral Tablet. One of these studies has progressed to the third phase of clinical trials. Although most testing for this drug is conducted in Winston-Salem North carolina, investigators have deployed tests at 4 other locations as well."
What is the uppermost limit of participants in this clinical experiment?
"Yes, the information available on clinicaltrials.gov confirms that this medical trial is actively enrolling participants. It was initially submitted to the website on November 2nd 2019 and its details were last updated on March 31st 2022. This study plans to recruit 100 patients at a single location."
To what degree is Risedronate Oral Tablet a hazard to individuals?
"The safety of Risedronate Oral Tablet is rated 3 by our team, since it has reached Phase 4 clinical trials and therefore been given approval."
Who meets the criteria for taking part in this experiment?
"This clinical trial seeks to enrol 100 individuals suffering from lobstein's disease, aged 6 and up. Applicants must meet the following criteria: diagnosis of OI type I, showing mild hearing loss as recorded by audiogram testing (>20dB pure tone average), 18 or over (child observational bisphosphonate arm only) currently receiving/not receiving standard care in form of bisphosphonates, vitamin d level above 30."
Is this trial limited to adults, or are minors allowed to participate?
"Appropriate candidates for this research trial must fall between 6 and 100 years of age."
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