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FOSAMAX PLUS and FOSAMAX PLUS D Re-examination Study (0217A-267)

NCT ID: NCT01065779

Last Updated: 2022-02-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

880 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2010-07-31

Brief Summary

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This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of FOSAMAX PLUS / FOSAMAX PLUS D through collecting the safety information according to the Re-examination Regulation for New Drugs.

Note: FOSAMAX PLUS D is known as FOSAMAX PLUS in several markets. FOSAMAX PLUS (70 mg/2800 IU) and FOSAMAX PLUS D (70 mg/5600 IU).

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Detailed Description

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Conditions

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Osteoporosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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FOSAMAX PLUS or FOSAMAX PLUS D

Patients with Osteoporosis treated with FOSAMAX PLUS (70 mg/2800 IU) or FOSAMAX PLUS D (70 mg/5600 IU).

FOSAMAX PLUS

Intervention Type DRUG

Patients with Osteoporosis treated with FOSAMAX PLUS (70 mg alendronate/2800 International Units (IU) Vitamin D). One tablet taken once weekly.

FOSAMAX PLUS D

Intervention Type DRUG

Patients with Osteoporosis treated with FOSAMAX PLUS D (70 mg alendronate/5600 IU Vitamin D). One tablet taken once weekly.

Interventions

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FOSAMAX PLUS

Patients with Osteoporosis treated with FOSAMAX PLUS (70 mg alendronate/2800 International Units (IU) Vitamin D). One tablet taken once weekly.

Intervention Type DRUG

FOSAMAX PLUS D

Patients with Osteoporosis treated with FOSAMAX PLUS D (70 mg alendronate/5600 IU Vitamin D). One tablet taken once weekly.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants who are treated with FOSAMAX PLUS / FOSAMAX PLUS D within label for the first time

Exclusion Criteria

* Participants who have a contraindication to FOSAMAX PLUS / FOSAMAX PLUS D according to the current local label
Minimum Eligible Age

18 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

Other Identifiers

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2010_007

Identifier Type: -

Identifier Source: secondary_id

0217A-267

Identifier Type: -

Identifier Source: org_study_id

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