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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
Child Observational Bisphosphonate Arm: Age 6-17 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Awards & highlights

Study 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 am 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.
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My child is not and will not be on bisphosphonate treatment during the study.

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
458 Previous Clinical Trials
470,833 Total Patients Enrolled
Hospital for Special Surgery, New YorkLead Sponsor
243 Previous Clinical Trials
59,264 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
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~10 spots leftby Nov 2024