A Research Study to Test the Effectiveness of MK0217 in Patients With Paget's Bone Disease (0217-206)(COMPLETED)

NCT ID: NCT00480662

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2002-10-31

Brief Summary

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To test the safety, effectiveness of MK0217 when taken once a week for six months in treating patients with Paget's bone disease.

Detailed Description

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Conditions

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Paget's Disease of Bone

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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alendronate

Duration of Treatment : 6 Months

Intervention Type DRUG

Other Intervention Names

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MK0217

Eligibility Criteria

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Inclusion Criteria

* Male or female, ages 18 to 90 years with a diagnosis of Paget's bone disease

Exclusion Criteria

* Patient cannot stand or sit upright for at least 30 minutes
* Patient has difficulty swallowing or problems with digestive system
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

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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Hooper M, Faustino A, Reid IR, Hosking D, Gilchrist NL, Selby P, Wu M, Salzmann G, West J, Leung A. Randomized, active-controlled study of once-weekly alendronate 280 mg high dose oral buffered solution for treatment of Paget's disease. Osteoporos Int. 2009 Jan;20(1):141-50. doi: 10.1007/s00198-008-0639-6. Epub 2008 Jun 7.

Reference Type RESULT
PMID: 18536953 (View on PubMed)

Other Identifiers

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MK0217-206

Identifier Type: -

Identifier Source: secondary_id

2007_555

Identifier Type: -

Identifier Source: secondary_id

0217-206

Identifier Type: -

Identifier Source: org_study_id

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