Alendronate Prevents Microarchitectural Deterioration of Trabecular Bone in Early Postmenopausal Women

This study has been completed.

Study NCT00504166 Information provided by University of California, San Francisco

First Received on July 17, 2007. Last Updated on July 13, 2011 History of Changes

Results First Received: July 13, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Prevention
Conditions:	Osteopenia Osteoporosis
Interventions:	Drug: alendronate sodium Other: placebo comparator

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
Recruitment period: Feb 2006-March 2007. Recruitment ads were posted at different UCSF campuses, senior centers, churches, train stations. We also utilized mass mailing lists, newspaper ad and radio broadcasts

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 Sodium	alendronate sodium 70 mg tablet once a week for 24 months
Placebo	placebo to match alendronate sodium

Participant Flow: Overall Study

	Alendronate Sodium	Placebo
STARTED	26	27
COMPLETED	20	13
NOT COMPLETED	6	14
Adverse Event	1	4
Withdrawal by Subject	3	6
Physician Decision	1	1
Lost to Follow-up	1	3

Baseline Characteristics

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Reporting Groups

	Description
Alendronate Sodium	alendronate sodium 70 mg tablet once a week for 24 months
Placebo	placebo to match alendronate sodium

Baseline Measures

	Alendronate Sodium	Placebo	Total
Number of Participants [units: participants]	26	27	53
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	26	27	53
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	55.8 ± 3.9	55.4 ± 3.3	55.6 ± 3.6
Gender [units: participants]
Female	26	27	53
Male	0	0	0
Region of Enrollment [units: participants]
United States	26	27	53

Outcome Measures

1. Primary:

Mean % Change From Baseline in Trabecular Number (Tb.N) by HR-pQCT [ Time Frame: 24 months ]

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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 NOT 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.

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: Dr. Thomas M. Link
Organization: University of California San Francisco
phone: 415-353-2450
e-mail: Thomas.Link@ucsf.edu

No publications provided

Responsible Party:	Thomas M. Link, MD, UC San Francisco
ClinicalTrials.gov Identifier:	NCT00504166 History of Changes
Other Study ID Numbers:	M250
Study First Received:	July 17, 2007
Results First Received:	July 13, 2011
Last Updated:	July 13, 2011
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board