|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
15 April 2024 |
|
Main ID: |
NCT04152551 |
|
Date of registration:
|
18/10/2019 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Effects of Bisphosphonates on OI-Related Hearing Loss
|
|
Scientific title:
|
Effects of Bisphosphonates on OI-Related Hearing Loss: A Pilot Study |
|
Date of first enrolment:
|
November 2, 2019 |
|
Target sample size:
|
100 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/ct2/show/NCT04152551 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Su Htwe |
|
Address:
|
|
|
Telephone:
|
(212)774-2355 |
|
Email:
|
htwes@hss.edu |
|
Affiliation:
|
|
|
|
Name:
|
Cathleen Raggio, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Hospital for Special Surgery, New York |
|
|
Name:
|
Su Htwe |
|
Address:
|
|
|
Telephone:
|
212-774-2355 |
|
Email:
|
htwes@hss.edu |
|
Affiliation:
|
|
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria (Adult Treatment Arm):
- Diagnosis of OI type I
- Diagnosis of at least mild hearing loss (>20dB pure tone average) by audiogram testing
- 18+
- Vitamin D level > 30
Inclusion Criteria (Adult Control Arm):
- Diagnosis of OI type I
Inclusion Criteria (Child Observational Bisphosphonate Arm)
- Diagnosis of OI
- Age 6-17 years
- Currently receiving bisphosphonate treatment as standard of care
Inclusion Criteria (Child Observational No Treatment Arm)
- Diagnosis of OI
- Age 6-17 years
- NOT receiving bisphosphonate treatment and will not receive bisphosphonate treatment
for the duration of the study
Exclusion Criteria (ALL ARMS):
- Family history of hearing-loss (not related to OI or occupational hearing loss)
- Pregnancy
Age minimum:
6 Years
Age maximum:
100 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Osteogenesis Imperfecta
|
|
Intervention(s)
|
|
Drug: Risedronate Oral Tablet
|
|
Primary Outcome(s)
|
|
Pure Tone Averages
[Time Frame: Baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months]
|
|
Secondary Outcome(s)
|
|
Hearing Handicap Inventory Raw Score
[Time Frame: Yearly (Baseline, 12, 24, 36, 48, 60 months)]
|
|
DEXA Bone Mineral Density
[Time Frame: Yearly (Baseline, 12, 24, 36, 48, 60 months)]
|
|
DEXA Z-score
[Time Frame: Yearly (Baseline, 12, 24, 36, 48, 60 months)]
|
|
SF-36 Scale and Summary Scores
[Time Frame: Yearly (Baseline, 12, 24, 36, 48, 60 months)]
|
|
Word Recognition Scores
[Time Frame: Baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months]
|
|
Pediatric Outcomes Data Collection Instrument (PODCI) Score
[Time Frame: Yearly (Baseline, 12, 24, 36, 48, 60 months)]
|
|
Adolescent Outcomes Questionnaire Score
[Time Frame: Yearly (Baseline, 12, 24, 36, 48, 60 months)]
|
|
Dizziness Handicap Inventory Score
[Time Frame: Yearly (Baseline, 12, 24, 36, 48, 60 months)]
|
|
Speech Recognition Scores
[Time Frame: Baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months]
|
|
Tinnitus Handicap Inventory Score
[Time Frame: Yearly (Baseline, 12, 24, 36, 48, 60 months)]
|
|
Secondary ID(s)
|
|
#2018-0700
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|