A Study to Evaluate the Safety and Tolerability of MK0217 in Women (0217-219)

NCT ID: NCT00092027

Last Updated: 2024-08-14

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

454 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-19

Study Completion Date

2004-03-15

Brief Summary

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This study is to assess the safety and tolerability of MK0217 being evaluated to treat women with postmenopausal osteoporosis.

Detailed Description

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Conditions

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Postmenopausal Osteoporosis

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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MK0217, alendronate sodium/Duration of Treatment: 6 months

Intervention Type DRUG

Comparator: placebo / Duration of Treatment: 6 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women with postmenopausal osteoporosis

Exclusion Criteria

* High risk for fractures
* Esophageal abnormalities
* Upper gastrointestinal symptoms that are not relieved with medication
* Metabolic bone disease (example - vitamin D deficiency)
* Medications that would affect the breakdown or build-up of bone
Minimum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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Cryer B, Binkley N, Simonelli C, Lewiecki EM, Lanza F, Chen E, Petruschke RA, Mullen C, de Papp AE. A randomized, placebo-controlled, 6-month study of once-weekly alendronate oral solution for postmenopausal osteoporosis. Am J Geriatr Pharmacother. 2005 Sep;3(3):127-36. doi: 10.1016/s1543-5946(05)80019-4.

Reference Type BACKGROUND
PMID: 16257815 (View on PubMed)

Other Identifiers

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MK0217-219

Identifier Type: -

Identifier Source: secondary_id

2004_017

Identifier Type: -

Identifier Source: secondary_id

0217-219

Identifier Type: -

Identifier Source: org_study_id

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