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

Organon

Status: Completed

Conditions: Osteoporosis

Treatments: Drug: FOSAMAX PLUS D; Drug: FOSAMAX PLUS

Study type: Observational

Funder types: Industry

Identifiers

NCT01065779

2010_007

0217A-267

Details and patient eligibility

About

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).

Enrollment: 880 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

880 participants in 1 patient group

FOSAMAX PLUS or FOSAMAX PLUS D

Description:

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

Treatment:

Drug: FOSAMAX PLUS D

Drug: FOSAMAX PLUS