Transition From Alendronate to Romosozumab (AMG 785)

Amgen60 enrolled

Overview

The purpose of this study is to estimate the percent change from baseline in lumbar spine bone mineral density (BMD) following multiple-dose administrations of romosozumab in postmenopausal women with low BMD previously treated with alendronate.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteoporosis

Interventions

RomosozumabDRUG

Administered by subcutaneous injection

Eligibility

Sex: FEMALEMin age: 55 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Postmenopausal women, defined as no vaginal bleeding or spotting for ≥ 12 months * Low bone mineral density at screening \[defined by a bone mineral density (BMD) T-score ≤ -2.0 and ≥ -4.0 at the lumbar spine (L1 to L4; or BMD T-score of evaluable vertebrae), total hip, or femoral neck\] * Currently taking alendronate (70 mg weekly or equivalent) exclusively for ≥ 1 year with verbal agreement that the subject has taken ≥ 80% of their doses with good tolerance Exclusion Criteria: * History of vertebral fracture, or fragility fracture of the wrist, humerus, hip or pelvis after age 50; or recent bone fracture within 6 months prior to screening * History of metabolic or bone disease such as Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome * Vitamin D deficiency (defined as 25-OH-VitD levels \< 20 ng/mL)

Locations (9)

Research Site

Tucson, Arizona, United States

Research Site

Walnut Creek, California, United States

Research Site

Gainesville, Georgia, United States

Research Site

Honolulu, Hawaii, United States

Outcomes

Primary Outcomes

Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine

Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans of the lumbar spine (L1-L4) and analyzed by a central imaging lab.

Time frame: Baseline and day 85

Secondary Outcomes

Percent Change From Baseline in Bone Mineral Density (BMD) at the Femoral Neck

Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans and analyzed by a central imaging lab.

Time frame: Baseline and day 85

Percent Change From Baseline in Bone Mineral Density (BMD) at the Total Hip

Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans and analyzed by a central imaging lab.

Time frame: Baseline and day 85

Percent Change From Baseline in Serum Type-1 Aminoterminal Propeptide (P1NP)

Time frame: Baseline and days 4, 15, 29, 43, 57, 71, and 85

Percent Change From Baseline in Serum C-telopeptide (sCTX)

Time frame: Baseline and days 4, 15, 29, 43, 57, 71, and 85

Number of Participants With Adverse Events

An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant. Laboratory value changes that required treatment or adjustment in current therapy were considered adverse events. A treatment-related adverse event (TRAE) was an adverse event assessed by the investigator as possibly related to the investigational product, indicated by a "yes" response to the question: Is there a reasonable possibility that the event may have been caused by the investigational product? A serious adverse event was defined as an adverse event that met at least 1 of the following serious criteria: * fatal, * life-threatening, * required in-patient hospitalization or prolongation of existing hospitalization, * resulted in persistent or significant disability/incapacity, * congenital anomaly/birth defect, and/or * other medically important serious event.

Data from ClinicalTrials.gov

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