RECRUITING

Effects of Bisphosphonates on OI-Related Hearing Loss

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Osteogenesis Imperfecta-related hearing loss usually occurs in individuals with mild (type I) OI and is much earlier in onset than age-related hearing loss, with the majority of individuals experiencing some minor hearing loss in their 20s. Bisphosphonates have been successfully used to treat otosclerosis, a common cause of hearing loss similar to OI-related hearing loss. As many individuals with OI-related hearing loss also present with otosclerosis and because of their mechanistic similarities, the investigators propose studying the effects of bisphosphonate treatment on individuals diagnosed with both OI type I and hearing loss, thereby determining its effectiveness as a potential treatment for hearing loss. The investigators will enroll 50 individuals diagnosed with type I OI and age 18-100. 25 adults will be enrolled into the treatment arm and receive bisphosphonate treatment (must have at least mild hearing loss), while 25 adults will be enrolled into the control arm. The investigators will enroll 25 children (6-17 years of age) diagnosed with OI who are currently receiving bisphosphonate treatment as part of their care for orthopedic symptoms. The investigators will also observe 25 children (6-17 years of age) diagnosed with OI who are NOT currently receiving bisphosphonate treatment. The study duration is 63 months (approximately 5 years). Enrollment is anticipated to begin in November 2019.

Official Title

Effects of Bisphosphonates on OI-Related Hearing Loss: A Pilot Study

Quick Facts

Study Start:2019-11-02
Study Completion:2024-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04152551

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Su Htwe
CONTACT
(212)774-2355
htwes@hss.edu
Erin Carter, MS, CGC
CONTACT
(212) 774-7332

Principal Investigator

Cathleen Raggio, MD
PRINCIPAL_INVESTIGATOR
Hospital for Special Surgery, New York

Study Locations (Sites)

Hospital for Special Surgery
New York, New York, 10021
United States

Collaborators and Investigators

Sponsor: Hospital for Special Surgery, New York

  • Cathleen Raggio, MD, PRINCIPAL_INVESTIGATOR, Hospital for Special Surgery, New York

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-11-02
Study Completion Date2024-11

Study Record Updates

Study Start Date2019-11-02
Study Completion Date2024-11

Terms related to this study

Keywords Provided by Researchers

  • hearing loss
  • bisphosphonate
  • skeletal dysplasia
  • brittle bone disorder
  • osteogenesis imperfecta
  • OI

Additional Relevant MeSH Terms

  • Osteogenesis Imperfecta