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

Amgen436 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

436

Conditions

Postmenopausal Osteoporosis

Interventions

RomozosumabDRUG

Administered by subcutaneous injection once a month.

TeriparatideDRUG

Administered by subcutaneous injection once a day.

Eligibility

Sex: FEMALEMin age: 55 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (50)

Outcomes

Primary Outcomes

Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD)

Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). Percent change from baseline through month 12 is the average of the treatment effect at months 6 and 12.

Time frame: Baseline, month 6 and month 12

Secondary Outcomes

Percent Change From Baseline in Total Hip BMD at Month 6

Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

Time frame: Baseline and month 6

Percent Change From Baseline in Total Hip BMD at Month 12

Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

Time frame: Baseline and month 12

Percent Change From Baseline in Cortical BMD by Quantitative Computed Tomography (QCT) at the Total Hip at Month 6

Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip.

Time frame: Baseline and month 6

Percent Change From Baseline in Cortical BMD by QCT at the Total Hip at Month 12

Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip.

Time frame: Baseline and month 12

Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 6

Integral BMD was measured by quantitative computed tomography (QCT) at the total hip.

Time frame: Baseline and month 6

Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 12

Data from ClinicalTrials.gov

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Research Site

Gainesville, Georgia, United States

Research Site

Bethesda, Maryland, United States

Research Site

Boston, Massachusetts, United States

Research Site

Boston, Massachusetts, United States

Research Site

Detroit, Michigan, United States

Research Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Research Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Research Site

Córdoba, Córdoba Province, Argentina

Research Site

Genk, Belgium

Research Site

Ghent, Belgium

...and 40 more locations