Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women

Pfizer

Status and phase: Completed; Phase 3

Conditions: Osteoporosis

Treatments: Other: Placebo; Drug: Bazedoxifene Acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00205777

B1781001

3068A1-301

Details and patient eligibility

About

The purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women.

Enrollment: 7,609 patients

Sex: Female

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be at least 2 years postmenopausal
• Osteoporotic subjects without vertebral fracture who meet BMD criteria, or Osteoporotic subjects with vertebral fracture

Exclusion criteria

• Diseases that may affect bone metabolism
• Vasomotor symptoms requiring treatment
• Known history or suspected cancer of the breast
• Active or past history of venous thromboembolic events

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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7,609 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Treatment:

Drug: Bazedoxifene Acetate

B

Placebo Comparator group

Treatment:

Other: Placebo