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

This study has been completed.

Study NCT00010439 Information provided by Medical University of South Carolina

First Received on February 2, 2001. Last Updated on October 21, 2010 History of Changes

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
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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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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 ]

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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 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Agreement with Merck: to submit a copy of any proposed abstract, manuscript and/or press release to Merck for review and comment at least 30 days prior to submission for publication or presentation.

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
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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