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Trial record 7 of 8 for:    "osteoporosis-pseudoglioma syndrome" OR "juvenile osteoporosis"

Safety and Efficacy of Alendronate (Fosamax) in Children With Osteoporosis

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ClinicalTrials.gov Identifier: NCT00259857
Recruitment Status : Completed
First Posted : December 1, 2005
Results First Posted : January 19, 2011
Last Update Posted : January 19, 2011
Sponsor:
Collaborators:
FDA Office of Orphan Products Development
Merck Sharp & Dohme Corp.
Information provided by:
Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Osteoporosis
Intervention Drug: Alendronate
Enrollment 22
Recruitment Details Dates of recruitment period:O5/27/2004 to 02/01/2006. Types of location:outpatient clinic, Clinical and Translational Research Center (CTRC), Medical University of South Carolina, Charleston, South Carolina.
Pre-assignment Details  
Arm/Group Title Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D
Hide Arm/Group Description Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements. Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
Period Title: 12 Months Treatment
Started 11 11
Completed 10 9
Not Completed 1 2
Reason Not Completed
Gr-1, lost followup; Gr-2, not compliant             1             2
Period Title: 24 Months Treatment
Started 10 9
Completed 10 6
Not Completed 0 3
Reason Not Completed
Lost to Follow-up             0             3
Arm/Group Title Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D Total
Hide Arm/Group Description Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements. Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements). Total of all reporting groups
Overall Number of Baseline Participants 11 11 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
<=18 years
11
 100.0%
11
 100.0%
22
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 11 participants 22 participants
9.17  (2.8) 9.47  (2.3) 9.32  (0.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
Female
4
  36.4%
7
  63.6%
11
  50.0%
Male
7
  63.6%
4
  36.4%
11
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 11 participants 22 participants
11 11 22
1.Primary Outcome
Title Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy
Hide Description Participants were screened for BMD of lumbar spine using DXA scan at visit 12 months after alendronate or placebo treatment.
Time Frame 12 months therapy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done per protocol and intention to treat.
Arm/Group Title Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D
Hide Arm/Group Description:
Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
Overall Number of Participants Analyzed 10 9
Measure Type: Number
Unit of Measure: participants
10 9
2.Primary Outcome
Title Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy
Hide Description BMD of lumbar spine was measured using DXA scan at visit 24 months (Year-2)after alendronate or placebo treatment.
Time Frame 24 months therapy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done per protocol and intention to treat.
Arm/Group Title Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D
Hide Arm/Group Description:
Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
Overall Number of Participants Analyzed 10 6
Measure Type: Number
Unit of Measure: participants
10 6
3.Secondary Outcome
Title Number of Participants With Improvement in Bone Mineral Density (BMD) of Hip After Therapy
Hide Description [Not Specified]
Time Frame 12 months of therapy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done per protocol and intention to treat.
Arm/Group Title Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D
Hide Arm/Group Description:
Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
Overall Number of Participants Analyzed 10 9
Measure Type: Number
Unit of Measure: participants
10 9
4.Secondary Outcome
Title Number of Participants With Improvement in BMD of Hip
Hide Description Analysis was done per protocol and intention to treat.
Time Frame 24 months of therapy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done per protocol and intention to treat.
Arm/Group Title Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D
Hide Arm/Group Description:
Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
Overall Number of Participants Analyzed 10 6
Measure Type: Number
Unit of Measure: participants
10 6
5.Secondary Outcome
Title Participants With Atraumatic Fractures
Hide Description Number of Participants with Atraumatic fractures before therapy.
Time Frame 0 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants with fractures before therapy.
Arm/Group Title Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D
Hide Arm/Group Description:
Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
Overall Number of Participants Analyzed 11 11
Measure Type: Number
Unit of Measure: participants
11 11
6.Secondary Outcome
Title Participants With Atraumatic Fractures
Hide Description Number of participants with fractures at the completion of therapy.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants with fractures at study completion.
Arm/Group Title Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D
Hide Arm/Group Description:
Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
Overall Number of Participants Analyzed 10 6
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame two years
Adverse Event Reporting Description To make monthly phone calls to assess any side effects or adverse events.
 
Arm/Group Title Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D
Hide Arm/Group Description Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements. Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
All-Cause Mortality
Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   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 0%
Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   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, MD, Asst.Professor, Pedeiatric 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: NCT00259857     History of Changes
Other Study ID Numbers: 5R01FD001847-05 ( U.S. FDA Grant/Contract )
FDR00184705-83045-05 ( Other Identifier: Medical University of South Carolina )
First Submitted: November 29, 2005
First Posted: December 1, 2005
Results First Submitted: November 9, 2010
Results First Posted: January 19, 2011
Last Update Posted: January 19, 2011