NCT01065779

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 880 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	FOSAMAX PLUS	Patients with Osteoporosis treated with FOSAMAX PLUS (70 mg alendronate/2800 International Units (IU) Vitamin D). One tablet taken once weekly.
DRUG	FOSAMAX PLUS D	Patients with Osteoporosis treated with FOSAMAX PLUS D (70 mg alendronate/5600 IU Vitamin D). One tablet taken once weekly.

Timeline

• Start date: 2006-03-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2010-02-09
• Last updated: 2022-02-03
• Results posted: 2011-09-13