Bisphosphonate Therapy for Osteogenesis Imperfecta

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00159419
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : March 31, 2016
Last Update Posted : June 14, 2017
Information provided by (Responsible Party):
Linda DiMeglio, MD, Indiana University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Osteogenesis Imperfecta
Paget Disease of Bone
Interventions: Drug: Alendronate
Drug: Pamidronate

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

Participant Flow:   Overall Study
    Pamidronate Treatment   Alendronate Treatment
STARTED   9   9 
COMPLETED   9   9 

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

Baseline Measures
   Pamidronate Treatment   Alendronate Treatment   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   9   18 
[Units: Participants]
Count of Participants
<=18 years      9 100.0%      9 100.0%      18 100.0% 
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% 
[Units: Years]
Mean (Full Range)
 (3.0 to 13.7) 
 (3.8 to 12.7) 
 (3.0 to 13.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      6  66.7%      5  55.6%      11  61.1% 
Male      3  33.3%      4  44.4%      7  38.9% 
Region of Enrollment 
[Units: Participants]
United States   9   9   18 

  Outcome Measures

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

  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: Dr. Linda DiMeglio
Organization: Indiana University School of Medicine
phone: 317-944-3889

Responsible Party: Linda DiMeglio, MD, Indiana University Identifier: NCT00159419     History of Changes
Other Study ID Numbers: 9902-30
First Submitted: September 7, 2005
First Posted: September 12, 2005
Results First Submitted: November 12, 2013
Results First Posted: March 31, 2016
Last Update Posted: June 14, 2017