Bisphosphonate Therapy for Osteogenesis Imperfecta

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Linda DiMeglio, MD, Indiana University
ClinicalTrials.gov Identifier:
NCT00159419
First received: September 7, 2005
Last updated: February 29, 2016
Last verified: February 2016
Results First Received: November 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Osteogenesis Imperfecta
Osteoporosis
Paget Disease of Bone
Interventions: Drug: Alendronate
Drug: Pamidronate

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruited from clinics

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
Pamidronate Treatment No text entered.
Alendronate Treatment No text entered.

Participant Flow:   Overall Study
    Pamidronate Treatment     Alendronate Treatment  
STARTED     9     9  
COMPLETED     9     9  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide 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
Pamidronate Treatment No text entered.
Alendronate Treatment No text entered.
Total Total of all reporting groups

Baseline Measures
    Pamidronate Treatment     Alendronate Treatment     Total  
Number of Participants  
[units: participants]
  9     9     18  
Age  
[units: participants]
     
<=18 years     9     9     18  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Full Range)
  8.4  
  (3.0 to 13.7)  
  9.0  
  (3.8 to 12.7)  
  8.7  
  (3.0 to 13.7)  
Gender  
[units: participants]
     
Female     6     5     11  
Male     3     4     7  
Region of Enrollment  
[units: participants]
     
United States     9     9     18  



  Outcome Measures

1.  Primary:   Bone Mineral Density   [ Time Frame: 2 years ]

2.  Secondary:   Pain Assessments   [ Time Frame: 6 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Bone Turnover Assessments   [ Time Frame: 6 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide More Information

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


Results Point of Contact:  
Name/Title: Dr. Linda DiMeglio
Organization: Indiana University School of Medicine
phone: 317-944-3889



Responsible Party: Linda DiMeglio, MD, Indiana University
ClinicalTrials.gov Identifier: NCT00159419     History of Changes
Other Study ID Numbers: 9902-30
Study First Received: September 7, 2005
Results First Received: November 12, 2013
Last Updated: February 29, 2016
Health Authority: United States: Institutional Review Board