A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis

Phase 3CompletedNCT00089791

Amgen7,808 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

7,808

Conditions

Osteoporosis

Interventions

placeboDRUG

Placebo administered by subcutaneous injection

DenosumabDRUG

Denosumab 60 mg administered by subcutaneous injection

Eligibility

Sex: FEMALEMin age: 60 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants With New Vertebral Fractures

A new vertebral fracture, assessed by lateral spine X-ray using Genant semiquantitative scoring method, was identified as an ≥ 1 grade increase from the Baseline grade of 0 in any vertebra from T4 to L4. New vertebral fractures included morphometric vertebral fractures (assessed at scheduled visits and not associated with signs or symptoms \[or both\] indicative of a fracture) and clinical vertebral fractures (assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms indicative of a fracture, excluding any fracture associated with high trauma severity or a pathologic fracture).

Time frame: 36 months

Secondary Outcomes

Number of Participants With Nonvertebral Fractures

Nonvertebral fractures (osteoporotic) were those occurring on study excluding those of the vertebrae (cervical, thoracic, and lumbar), skull, facial, mandible, metacarpus, finger phalanges, and toe phalanges. Fractures associated with high trauma severity (fractures that were the result of a fall from higher than the height of a stool, chair, first rung on a ladder or equivalent (\> 20 inches) or was the result of severe trauma other than a fall) and pathologic fractures were excluded from this category. Nonvertebral fractures were required to be confirmed either by radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging (MRI), or by documentation in a radiology report, surgical report, or discharge summary.

Time frame: 36 months

Number of Participants With a Hip Fracture

Hip fractures are a subset of nonvertebral fractures including femur neck, femur intertrochanter, and femur subtrochanter.

Time frame: 36 months

Data from ClinicalTrials.gov

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