Clinical trial NCT01588509: Transition From Alendronate to Romosozumab (AMG 785)
Official title: An Open-label, Randomized Study to Estimate the Percent Change From Baseline in Lumbar Spine Bone Mineral Density After 3 Months of AMG 785 Administration in Postmenopausal Women With Low Bone Mineral Density Previously Treated With Alendronate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Keywords: AMG 785, bone mineral density, alendronate
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2012-05-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine
timeFrame: Baseline and day 85
Secondary outcomes:
measure: Percent Change From Baseline in Bone Mineral Density (BMD) at the Femoral Neck
timeFrame: Baseline and day 85
measure: Percent Change From Baseline in Bone Mineral Density (BMD) at the Total Hip
timeFrame: Baseline and day 85
measure: Percent Change From Baseline in Serum Type-1 Aminoterminal Propeptide (P1NP)
timeFrame: Baseline and days 4, 15, 29, 43, 57, 71, and 85
measure: Percent Change From Baseline in Serum C-telopeptide (sCTX)
timeFrame: Baseline and days 4, 15, 29, 43, 57, 71, and 85
measure: Number of Participants With Adverse Events
timeFrame: From first dose of study drug up to day 85
measure: Number of Participants Who Developed Anti-romosozumab Antibodies
timeFrame: Baseline and days 29, 57, and 85
measure: Mean Serum Concentration of Romosozumab
timeFrame: Days 4, 15, 29, 43, 57, 71 and 85
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Walnut Creek
country: United States
facility: Research Site
state: California
city: Gainesville
country: United States
facility: Research Site
state: Georgia
city: Honolulu
country: United States
facility: Research Site
state: Hawaii
city: Bethesda
country: United States
facility: Research Site
state: Maryland
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: West Haverstraw
country: United States
facility: Research Site
state: New York
city: Wyomissing
country: United States
facility: Research Site
state: Pennsylvania
city: Seattle
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: