CClinicalTrials.gg
WithdrawnNCT01614171GHOPPGUpdated Apr 8, 2022

Growth Hormone for Osteoporosis Pseudoglioma Syndrome

An interventional study of Human recombinant growth hormone in Osteoporosis Pseudoglioma Syndrome, sponsored by University of Maryland, Baltimore. Withdrawn at 1 site in United States. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2022-04-08.

Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Treatment

Why this study was withdrawn
it was never started because it was never funded
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
4 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Osteoporosis Pseudoglioma Syndrome

Keywords

  • osteoporosis pseudoglioma
  • OPPG
  • growth hormone
  • osteoporosis
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

Browse Osteoporosis studies →

Lead sponsor

University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Osteoporosis pseudoglioma syndrome
  • Age 4 years and above
  • not on medication for osteoporosis

Exclusion criteria

Exclusion Criteria:

  • pregnant
  • Age under 4 yrs
  • Active malignancy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Growth hormone therapy

    Growth hormone treatment for 6 months

    Biological: Human recombinant growth hormone

Interventions

  • BiologicalHuman recombinant growth hormone

    growth hormone treatment for 6 months (daily, weight based)

06

What researchers measure

Primary outcomes

  1. Bone quality by pQCT

    By pQCT: periosteal circumference, cortical density, trabecular density, section modulus

    Time frame: 6 months

Secondary outcomes

  1. Body fat percent

    Percent body fat by DXA

    Time frame: 6 months

07

Study locations

1 site
  • University of Maryland School of Medicine
    Baltimore, Maryland 21201, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01614171
Lead sponsor
University of Maryland, Baltimore
Collaborators
Children's Hospital of Philadelphia
Responsible party
Elizabeth Streeten (Associate Professor of Medicine, University of Maryland, Baltimore) — Principal investigator
First posted
Jun 7, 2012
Start date
Dec 2013
Primary completion
Dec 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
Apr 8, 2022

Study contacts

Elizabeth A Streeten, MD
principal investigator · University of Maryland School of Medicine, Division of Endocrinology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion