Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis (FRAME)

Amgen

Status and phase: Completed; Phase 3

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: Romosozumab; Drug: Placebo; Drug: Denosumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01575834

2011-001456-11 (EudraCT Number)

20070337

Details and patient eligibility

About

The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis

Enrollment: 7,180 patients

Sex: Female

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal women with osteoporosis, defined as low bone mineral density (BMD T-score at the total hip or femoral neck of ≤ -2.50)

Exclusion criteria

• BMD T-score of ≤ -3.50 at the total hip or femoral neck
• History of hip fracture
• Any severe or more than 2 moderate vertebral fractures, as assessed by the central imaging based on lateral spine x-rays
• Use of agents affecting bone metabolism
• History of metabolic or bone disease (except osteoporosis)
• Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
• Current hyper- or hypocalcemia
• Current, uncontrolled hyper- or hypothyroidism
• Current, uncontrolled hyper- or hypoparathyroidism

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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7,180 participants in 2 patient groups, including a placebo group

Romosozumab

Experimental group

Description:

Participants received 210 mg romosozumab subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.

Treatment:

Drug: Denosumab

Drug: Romosozumab

Placebo

Placebo Comparator group

Description:

Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.

Treatment:

Drug: Denosumab

Drug: Placebo