Transition From Alendronate to Romosozumab (AMG 785)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01588509|
Recruitment Status : Completed
First Posted : May 1, 2012
Results First Posted : March 4, 2019
Last Update Posted : March 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis||Drug: Romosozumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 30, 2012|
|Actual Primary Completion Date :||November 21, 2012|
|Actual Study Completion Date :||November 21, 2012|
Experimental: Romosozumab 140 mg
Participants received romosozumab 140 mg administered subcutaneously once a month for 3 months.
Administered by subcutaneous injection
Experimental: Romosozumab 210 mg
Participants received romosozumab 210 mg administered subcutaneously once a month for 3 months.
Administered by subcutaneous injection
- Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine [ Time Frame: Baseline and day 85 ]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.
- Percent Change From Baseline in Bone Mineral Density (BMD) at the Femoral Neck [ Time Frame: Baseline and day 85 ]Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans and analyzed by a central imaging lab.
- Percent Change From Baseline in Bone Mineral Density (BMD) at the Total Hip [ Time Frame: Baseline and day 85 ]Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans and analyzed by a central imaging lab.
- 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 [ Time Frame: From first dose of study drug up to day 85 ]
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:
- 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.
- Number of Participants Who Developed Anti-romosozumab Antibodies [ Time Frame: Baseline and days 29, 57, and 85 ]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.
- Mean Serum Concentration of Romosozumab [ Time Frame: Days 4, 15, 29, 43, 57, 71 and 85 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01588509
|United States, Arizona|
|Tucson, Arizona, United States, 85711|
|United States, California|
|Walnut Creek, California, United States, 94598|
|United States, Georgia|
|Gainesville, Georgia, United States, 30501|
|United States, Hawaii|
|Honolulu, Hawaii, United States, 96813|
|United States, Maryland|
|Bethesda, Maryland, United States, 20817|
|United States, New Mexico|
|Albuquerque, New Mexico, United States, 87106|
|United States, New York|
|West Haverstraw, New York, United States, 10993|
|United States, Pennsylvania|
|Wyomissing, Pennsylvania, United States, 19610|
|United States, Washington|
|Seattle, Washington, United States, 98144|