A Study of MK0217A and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

652 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2004-11-30

Brief Summary

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The purpose of this study is to test the safety, tolerability, and effectiveness of an investigational drug and dietary supplement to reduce the risk of vitamin D insufficiency and deficiency during treatment of osteoporosis in men and postmenopausal women.

Detailed Description

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Conditions

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Osteoporosis Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 24 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men or postmenopausal women who are osteoporotic

Exclusion Criteria

* Vitamin D deficiency
* Other disease of bone or mineral metabolism
* Digestive disease causing malabsorption
* Other medical conditions that are not adequately treated

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitior

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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Recker R, Lips P, Felsenberg D, Lippuner K, Benhamou L, Hawkins F, Delmas PD, Rosen C, Emkey R, Salzmann G, He W, Santora AC. Alendronate with and without cholecalciferol for osteoporosis: results of a 15-week randomized controlled trial. Curr Med Res Opin. 2006 Sep;22(9):1745-55. doi: 10.1185/030079906x120913.

Reference Type BACKGROUND

PMID: 16968578 (View on PubMed)

Binkley N, Ringe JD, Reed JI, Ljunggren O, Holick MF, Minne HW, Liu M, Lamotta A, West JA, Santora AC. Alendronate/vitamin D3 70 mg/2800 IU with and without additional 2800 IU vitamin D3 for osteoporosis: results from the 24-week extension of a 15-week randomized, controlled trial. Bone. 2009 Apr;44(4):639-47. doi: 10.1016/j.bone.2008.05.002. Epub 2008 May 15.