CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 880 enrolled
Drug / intervention
FOSAMAX PLUS +1 moredrug
Likely dose
FOSAMAX PLUS 70 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01065779
NCT01065779N/ACompleted
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Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of FOSAMAX PLUS and FOSAMAX PLUS D in Usual Practice

Organon and Co·observational·Posted Feb 9, 2010·Updated Feb 3, 2022

In Brief

An observational study evaluating FOSAMAX PLUS and FOSAMAX PLUS D for Osteoporosis. Completed, enrolled 880 participants.

Detailed Summary

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).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
Countries--
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 9, 2010
Enrollment StartMar 1, 2006
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 16.4 years ago

Interventions

FOSAMAX PLUSdrug

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

FOSAMAX PLUS Ddrug

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