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

Condition(s) targeted: Osteoporosis

Intervention: FOSAMAX PLUS (Drug); FOSAMAX PLUS D (Drug)

Phase: N/A

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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).

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

Study design: Time Perspective: Prospective

Primary outcome:

Number of Participants With Serious Adverse Events

Number of Participants With Unexpected Adverse Events

Number of Participants With Non-Serious AEs

Number of Participants With Improved, Unchanged, or Worsened Disease

Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment

Change From Baseline in Serum Osteocalcin at End of Treatment

Change From Baseline in Urine Deoxypyridinoline at End of Treatment

Change From Baseline in Alkaline Phosphatase at End of Treatment

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Starting date: March 2006
Last updated: July 17, 2015