An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women (STRUCTURE)

Amgen

Status and phase: Completed; Phase 3

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: Romozosumab; Drug: Teriparatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01796301

20080289

2012-002948-24 (EudraCT Number)

Details and patient eligibility

About

The primary objective of the study was to evaluate the effect of 12 months of treatment with romosozumab compared with teriparatide on total hip bone mineral density (BMD) in postmenopausal women with osteoporosis who were previously treated with bisphosphonate therapy.

Enrollment: 436 patients

Sex: Female

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal women, aged ≥ 55 to ≤ 90.
• Received oral bisphosphonate therapy for at least 3 years immediately prior to screening
• BMD T-score ≤ -2.50 at the lumbar spine, total hip or femoral neck
• History of nonvertebral fracture after age 50, or vertebral fracture.

Exclusion criteria

• Use of other agents affecting bone metabolism including Strontium ranelate, fluoride (for osteoporosis), odanacatib (MK-0822) or any other cathepsin K inhibitor, IV bisphosphonates, denosumab, teriparatide (TPTD) or any parathyroid hormone (PTH) analogs, Systemic oral or transdermal estrogen, selective estrogen receptor modulators (SERMs), activated vitamin D3, vitamin K2, calcitonin, tibolone, cinacalcet, systemic glucocorticosteroids:
• History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of study results, such as sclerosteosis, Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome.
• Vitamin D insufficiency, defined as 25 (OH) vitamin D levels < 20 ng/mL, as determined by the central laboratory.
• Current hyper- or hypocalcemia
• Current, uncontrolled hyper- or hypothyroidism

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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436 participants in 2 patient groups

Romosozumab

Experimental group

Description:

Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.

Treatment:

Drug: Romozosumab

Teriparatide

Active Comparator group

Description:

Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.

Treatment:

Drug: Teriparatide