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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)
Enrollment 11
Recruitment Details 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 Participants should have completed our earlier phase I or II study on alendronate in juvenile osteoporosis. Participants will be recruited by invitation only.
Arm/Group Title 1 Alendronate for 12 Months, Post Study
Hide Arm/Group Description 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.
Period Title: Last Study, 25 Pts Invited,11 Responded
Started 11
Completed 11
Not Completed 0
Period Title: Post Study, 11 Pts Responded
Started 11
Completed 11
Not Completed 0
Arm/Group Title 1 Alendronate for 12 Months, Post Study
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
11
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
12.9  (2.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
6
  54.5%
Male
5
  45.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Bone Mineral Density (BMD) of the Lumbar Spine (Participants With Percentage Increase).
Hide Description Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Bone density of spine was measured by DXA scan.
Time Frame Post study (1-6 yrs), one clinical visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who earlier completed our phase I or phase II study on alendronate in juvenile osteoporosis, were invited to participate in the current post study evaluation of bone density and fractures.
Arm/Group Title 1 Alendronate for 12 Months, Post Study
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
11
2.Secondary Outcome
Title Bone Mineral Density (BMD) of the Hip (Participants With Percentage Increase).
Hide Description Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Bone density of hip was measured by DXA scan.
Time Frame Post study (1-6 years), one clincial visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
11 participants responded to participate in the post study. Their bone density of Hip was measured by DXA scan. Increase in percentage density of Hip was obtained from that of previous values. One participant showed a slight decrease in bone density.
Arm/Group Title 1 Alendronate for 12 Months, Post Study
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
10
3.Secondary Outcome
Title Number of Participants With Fracture
Hide Description Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Their bone densities of spine and hip were measured by DXA scan. During this visit, their fracture history was obtained.
Time Frame Post study (1-6 years), one clinical visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
11 participants responded to participate in the post study. During their one clinic visit, their fracture history during the period before coming to the post study was obtained.
Arm/Group Title 1 Alendronate for 12 Months, Post Study
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
0
Time Frame 1-6 years post study
Adverse Event Reporting Description Participants who completed our earlier phase I/II study on alendronate in juvenile osteoporosis were invited to participate in the current post study evaluation of their current bone density/fracure history. Durine their one time clinic visit, they were asked regarding any adverse events they had during the period before coming to the post study.
 
Arm/Group Title 1 Alendronate for 12 Months, Post Study
Hide Arm/Group Description 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.
All-Cause Mortality
1 Alendronate for 12 Months, Post Study
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
1 Alendronate for 12 Months, Post Study
Affected / at Risk (%)
Total   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1 Alendronate for 12 Months, Post Study
Affected / at Risk (%)
Total   0/11 (0.00%) 
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
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