Transition From Alendronate to Romosozumab (AMG 785)

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01588509
• Other study ID #: 20110253
• Status: Completed
• Phase: Phase 1
• Start date: March 30, 2012
• Est. completion date: November 21, 2012

Study information

• Verified date: March 2019
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 21, 2012
• Est. primary completion date: November 21, 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Romosozumab
Administered by subcutaneous injection

Locations

Country	Name	City	State
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Bethesda	Maryland
United States	Research Site	Gainesville	Georgia
United States	Research Site	Honolulu	Hawaii
United States	Research Site	Seattle	Washington
United States	Research Site	Tucson	Arizona
United States	Research Site	Walnut Creek	California
United States	Research Site	West Haverstraw	New York
United States	Research Site	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and day 85
Secondary	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.	Baseline and day 85
Secondary	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.	Baseline and day 85
Secondary	Percent Change From Baseline in Serum Type-1 Aminoterminal Propeptide (P1NP)		Baseline and days 4, 15, 29, 43, 57, 71, and 85
Secondary	Percent Change From Baseline in Serum C-telopeptide (sCTX)		Baseline and days 4, 15, 29, 43, 57, 71, and 85
Secondary	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.	From first dose of study drug up to day 85
Secondary	Number of Participants Who Developed Anti-romosozumab Antibodies	Two validated assays were used to detect the presence of anti-romosozumab antibodies. An electrochemiluminescent bridging immunoassay was used to detect binding antibodies (screening assay) and confirm antibodies (confirmatory assay) capable of binding romosozumab. Samples testing positive in the immunoassay were further tested in a competitive binding bioassay for neutralizing activity against romosozumab. If a sample was positive for binding antibodies and demonstrated neutralizing activity, the participant was defined as positive for neutralizing antibodies. Participants who developed anti-romosozumab antibodies were those with a negative result at baseline and a positive result at any time postbaseline.	Baseline and days 29, 57, and 85
Secondary	Mean Serum Concentration of Romosozumab		Days 4, 15, 29, 43, 57, 71 and 85

External Links

•   AmgenTrials clinical trials website