Secondary Prevention of Osteoporosis

This study has been completed.

Study NCT00421343 Information provided by Hebrew Rehabilitation Center, Boston

First Received on January 10, 2007. Last Updated on May 11, 2011 History of Changes

Results First Received: July 8, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Osteoporosis
Interventions:	Drug: alendronate with cholecalciferol Drug: calcium carbonate with cholecalciferol Behavioral: Falls prevention measures

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
none

Reporting Groups

	Description
Osteoporosis Medication	Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.

Participant Flow: Overall Study

	Osteoporosis Medication
STARTED	29
COMPLETED	23
NOT COMPLETED	6
Death	1
Withdrawal by Subject	2
Lost to follow-up	3

Baseline Characteristics

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Reporting Groups

	Description
Osteoporosis Medication	Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.

Baseline Measures

	Osteoporosis Medication
Number of Participants [units: participants]	29
Age [units: participants]
<=18 years	0
Between 18 and 65 years	1
>=65 years	28
Age [units: years] Mean ± Standard Deviation	80 ± 10
Gender [units: participants]
Female	26
Male	3
Region of Enrollment [units: participants]
United States	29

Outcome Measures

1. Primary:

Number Adherent With the Intervention [ Time Frame: 6 months ]

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2. Secondary:

Reasons for Non-willingness to Particiapte and Non-adherence With Intervention [ Time Frame: 6 months ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

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: Sarah Berry
Organization: Hebrew SeiorLife
phone: 617-971-5355
e-mail: sarahberry@hrca.harvard.edu

Publications:

Kamel HK. Secondary prevention of hip fractures among the hospitalized elderly: are we doing enough? J Clin Rheumatol. 2005 Apr;11(2):68-71.

Dawson-Hughes B, Harris SS, Krall EA, Dallal GE. Effect of calcium and vitamin D supplementation on bone density in men and women 65 years of age or older. N Engl J Med. 1997 Sep 4;337(10):670-6.

Cummings SR, Black DM, Thompson DE, Applegate WB, Barrett-Connor E, Musliner TA, Palermo L, Prineas R, Rubin SM, Scott JC, Vogt T, Wallace R, Yates AJ, LaCroix AZ. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial. JAMA. 1998 Dec 23-30;280(24):2077-82.

Gillespie LD, Gillespie WJ, Robertson MC, Lamb SE, Cumming RG, Rowe BH. Interventions for preventing falls in elderly people. Cochrane Database Syst Rev. 2003;(4):CD000340. Review.

Feldstein A, Elmer PJ, Orwoll E, Herson M, Hillier T. Bone mineral density measurement and treatment for osteoporosis in older individuals with fractures: a gap in evidence-based practice guideline implementation. Arch Intern Med. 2003 Oct 13;163(18):2165-72.

Responsible Party:	Sarah D. Berry, MD, MPH, Harvard University, Hebrew Rehabilitation Center
ClinicalTrials.gov Identifier:	NCT00421343 History of Changes
Other Study ID Numbers:	AG0074, 5T32AG023480-03
Study First Received:	January 10, 2007
Results First Received:	July 8, 2010
Last Updated:	May 11, 2011
Health Authority:	United States: Federal Government