Phase II Study of Alendronate Sodium in Children With High-Turnover Idiopathic Juvenile Osteoporosis

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00010439
First received: February 2, 2001
Last updated: October 21, 2010
Last verified: October 2010
Results First Received: June 3, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Osteoporosis
Intervention: Drug: Alendronate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Dates of the recruitment period: 5/3/2001 to 7/23/2002. Types of location: Out-patient clinic, Clinical and Translational Research Center (CTRC, formerly General Clinical Research Center), Medical University of 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
Alendronate Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.

Participant Flow:   Overall Study
    Alendronate  
STARTED     10  
6 Months     10  
COMPLETED     10  
NOT COMPLETED     0  



  Baseline Characteristics
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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
Alendronate Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.

Baseline Measures
    Alendronate  
Number of Participants  
[units: participants]
  10  
Age  
[units: participants]
 
<=18 years     10  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
 
Pre-Treatment (Baseline)     9.4  ± 2.3  
Post Treatment     10.6  ± 2.3  
Gender  
[units: participants]
 
Female     5  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     10  



  Outcome Measures
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1.  Primary:   Number of Participants With Increased Bone Mineral Density   [ Time Frame: at 12 months ]

2.  Secondary:   Participants (1) With Fractures Before and After Therapy,(2)Analysed for Average Changes From High to Near Normal Mineral Apposition Rate (MAR) After Therapy,(3)Analysed for Average Insignificant Changes in Biochemical Markers After Therapy.   [ Time Frame: Before and 12 months after treatment with alendronate ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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.  


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


Publications of Results:
1. Key LL Jr., Ries w, Madyastha P, Reed F: Juvenile Osteoporosis: recognizing the risk. J Pediatr Endocrinol Metab. 2003 May; 16 Suppl 3:683-6, PMID: 12795371 2. P Madyastha, W Ries, B Hollis, F Reed, L Key. Alendronate improved bone mineral density in patients with juvenile osteoporosis. JBMR 20:Suppl 1, page S400, 2005.


Responsible Party: Deborah A Bowlby, MD., Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00010439     History of Changes
Other Study ID Numbers: 199/15705, FD-R-001847-01
Study First Received: February 2, 2001
Results First Received: June 3, 2009
Last Updated: October 21, 2010
Health Authority: United States: Food and Drug Administration