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Trial record 3 of 8 for:    "osteoporosis-pseudoglioma syndrome" OR "juvenile osteoporosis"

Alendronate in Juvenile Osteoporosis

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ClinicalTrials.gov Identifier: NCT00920075
Recruitment Status : Completed
First Posted : June 15, 2009
Results First Posted : December 10, 2010
Last Update Posted : July 11, 2018
Sponsor:
Collaborators:
FDA Office of Orphan Products Development
Merck Sharp & Dohme Corp.
Information provided by:
Medical University of South Carolina

Study Type: Observational
Study Design: Observational Model: Other;   Time Perspective: Other
Conditions: Juvenile Osteoporosis
Low Bone Density
Fractures
Intervention: Drug: Alendronate (Fosamax)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants who have completed our earlier phase-1 and II study on alendronate in juvenile osteoporosis will be invited in this post study to evaluate the bone density/ fractures after discontinuation of therapy. Interested participants will be scheduled for a one time clinic visit. No treatment is involved.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants should have completed our earlier phase I or II study on alendronate in juvenile osteoporosis. Participants will be recruited by invitation only.

Reporting Groups
  Description
1 Alendronate for 12 Months, Post Study Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.

Participant Flow for 2 periods

Period 1:   Last Study, 25 Pts Invited,11 Responded
    1 Alendronate for 12 Months, Post Study
STARTED   11 
COMPLETED   11 
NOT COMPLETED   0 

Period 2:   Post Study, 11 Pts Responded
    1 Alendronate for 12 Months, Post Study
STARTED   11 
COMPLETED   11 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1 Alendronate for 12 Months, Post Study Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.

Baseline Measures
   1 Alendronate for 12 Months, Post Study 
Overall Participants Analyzed 
[Units: Participants]
 11 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      11 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 12.9  (2.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      6  54.5% 
Male      5  45.5% 
Region of Enrollment 
[Units: Participants]
 
United States   11 


  Outcome Measures

1.  Primary:   Bone Mineral Density (BMD) of the Lumbar Spine (Participants With Percentage Increase).   [ Time Frame: Post study (1-6 yrs), one clinical visit ]

2.  Secondary:   Bone Mineral Density (BMD) of the Hip (Participants With Percentage Increase).   [ Time Frame: Post study (1-6 years), one clincial visit ]

3.  Secondary:   Number of Participants With Fracture   [ Time Frame: Post study (1-6 years), one clinical visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Deborah A Bowlby, Asst.Professor, Pediatric Endocrinology
Organization: Medical University of South Carolina
phone: 843-792-6807
e-mail: bowlbyd@musc.edu


Publications of Results:

Responsible Party: Deborah A Bowlby, MD, Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00920075     History of Changes
Other Study ID Numbers: 5R01FD001847-05 REVISED
FD-R-001847-03 ( Other Identifier: FDA )
5R01FD001847-05 ( U.S. NIH Grant/Contract )
First Submitted: June 11, 2009
First Posted: June 15, 2009
Results First Submitted: November 9, 2010
Results First Posted: December 10, 2010
Last Update Posted: July 11, 2018