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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D 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.
Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D 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).

Participant Flow for 2 periods

Period 1:   12 Months Treatment
    Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D   Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D
STARTED   11   11 
COMPLETED   10   9 
NOT COMPLETED   1   2 
Gr-1, lost followup; Gr-2, not compliant                1                2 

Period 2:   24 Months Treatment
    Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D   Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D
STARTED   10   9 
COMPLETED   10   6 
NOT COMPLETED   0   3 
Lost to Follow-up                0                3 



  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
Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D 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.
Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D 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 Total of all reporting groups

Baseline Measures
   Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D   Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   11   22 
Age 
[Units: Participants]
     
<=18 years   11   11   22 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 9.17  (2.8)   9.47  (2.3)   9.32  (0.2) 
Gender 
[Units: Participants]
     
Female   4   7   11 
Male   7   4   11 
Region of Enrollment 
[Units: Participants]
     
United States   11   11   22 


  Outcome Measures

1.  Primary:   Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy   [ Time Frame: 12 months therapy ]

2.  Primary:   Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy   [ Time Frame: 24 months therapy ]

3.  Secondary:   Number of Participants With Improvement in Bone Mineral Density (BMD) of Hip After Therapy   [ Time Frame: 12 months of therapy ]

4.  Secondary:   Number of Participants With Improvement in BMD of Hip   [ Time Frame: 24 months of therapy ]

5.  Secondary:   Participants With Atraumatic Fractures   [ Time Frame: 0 months ]

6.  Secondary:   Participants With Atraumatic Fractures   [ Time Frame: 24 months ]


  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, MD, Asst.Professor, Pedeiatric 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: 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