A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis

Amgen

Status and phase: Completed; Phase 3

Conditions: Osteoporosis

Treatments: Drug: Denosumab; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00089791

20030216

Details and patient eligibility

About

This study will evaluate the effectiveness and safety of denosumab in treating women with Postmenopausal Osteoporosis.

Enrollment: 7,808 patients

Sex: Female

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women who are 60 to 90 years of age may be eligible to participate
• Bone mineral density (BMD) T-Score at hip or spine must be less than -2.5

Exclusion criteria

• BMD T-Score at the hip or the spine of less than -4.0
• Patients with any severe or more than two moderate vertebral fractures on spinal x-ray at entry

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

7,808 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo administered subcutaneously once every 6 months for 3 years.

Treatment:

Drug: placebo

Denosumab 60 mg Q6M

Experimental group

Description:

Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.

Treatment:

Drug: Denosumab