A Study and 12 Month Extension to Evaluate Two Investigational Drugs in Postmenopausal Women With Osteoporosis (MK-0217-907)

NCT ID: NCT00092040

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

936 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-18

Study Completion Date

2005-09-28

Brief Summary

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The purpose of this study and 12 month extension is to evaluate the effects of two investigational drugs on osteoporosis in postmenopausal women.

Detailed Description

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Conditions

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Osteoporosis, Postmenopausal

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 Intervention: 12 mo

Intervention Type DRUG

Comparator: risedronate / Duration of Intervention: 12 mo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal women with osteoporosis

Exclusion Criteria

* Any known allergy to the study drug
Minimum Eligible Age

40 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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Reid DM, Hosking D, Kendler D, Brandi ML, Wark JD, Weryha G, Marques-Neto JF, Gaines KA, Verbruggen N, Melton ME. Alendronic acid produces greater effects than risedronic acid on bone density and turnover in postmenopausal women with osteoporosis : results of FACTS -international. Clin Drug Investig. 2006;26(2):63-74. doi: 10.2165/00044011-200626020-00002.

Reference Type BACKGROUND
PMID: 17163237 (View on PubMed)

Reid DM, Hosking D, Kendler D, Brandi ML, Wark JD, Marques-Neto JF, Weryha G, Verbruggen N, Hustad CM, Mahlis EM, Melton ME. A comparison of the effect of alendronate and risedronate on bone mineral density in postmenopausal women with osteoporosis: 24-month results from FACTS-International. Int J Clin Pract. 2008 Apr;62(4):575-84. doi: 10.1111/j.1742-1241.2008.01704.x.

Reference Type BACKGROUND
PMID: 18324951 (View on PubMed)

Other Identifiers

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2004_019

Identifier Type: -

Identifier Source: secondary_id

0217-907

Identifier Type: -

Identifier Source: org_study_id

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