- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01614171
Growth Hormone for Osteoporosis Pseudoglioma Syndrome (GHOPPG)
March 30, 2022 updated by: Elizabeth Streeten, University of Maryland, Baltimore
Trial of Growth Hormone for Osteoporosis Pseudoglioma Syndrome
Osteoporosis pseudoglioma (OPPG) syndrome is a rare autosomal recessive condition of childhood osteoporosis and congenital blindness for which new treatments are needed.
We have found that body fat is increased in OPPG and muscle mass is reduced.
We hypothesize that growth hormone therapy will improve muscle mass and bone strength in OPPG.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
Osteoporosis pseudoglioma (OPPG) syndrome is a rare autosomal recessive condition of childhood osteoporosis and congenital blindness for which new treatments are needed.
We have found that body fat is increased in OPPG and muscle mass is reduced.
We hypothesize that growth hormone therapy will improve muscle mass and bone strength in OPPG.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- University of Maryland School of Medicine
-
-
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.
Eligibility Criteria
Ages Eligible for Study
4 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Osteoporosis pseudoglioma syndrome
- Age 4 years and above
- not on medication for osteoporosis
Exclusion Criteria:
- pregnant
- Age under 4 yrs
- Active malignancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Growth hormone therapy
Growth hormone treatment for 6 months
|
growth hormone treatment for 6 months (daily, weight based)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bone quality by pQCT
Time Frame: 6 months
|
By pQCT: periosteal circumference, cortical density, trabecular density, section modulus
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body fat percent
Time Frame: 6 months
|
Percent body fat by DXA
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Elizabeth A Streeten, MD, University of Maryland School of Medicine, Division of Endocrinology
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 Major Dates
Study Start
December 1, 2013
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
June 5, 2012
First Submitted That Met QC Criteria
June 5, 2012
First Posted (Estimate)
June 7, 2012
Study Record Updates
Last Update Posted (Actual)
April 8, 2022
Last Update Submitted That Met QC Criteria
March 30, 2022
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Epilepsy, Generalized
- Epileptic Syndromes
- Eye Diseases
- Neurologic Manifestations
- Disease
- Genetic Diseases, Inborn
- Musculoskeletal Diseases
- Connective Tissue Diseases
- Bone Diseases
- Sensation Disorders
- Bone Diseases, Metabolic
- Bone Diseases, Developmental
- Vision Disorders
- Osteochondrodysplasias
- Collagen Diseases
- Epilepsy
- Syndrome
- Osteoporosis
- Osteogenesis Imperfecta
- Blindness
- Spasms, Infantile
- Genetic Diseases, X-Linked
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormones
Other Study ID Numbers
- HP-00053014
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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