Transition From Alendronate to AMG 785
This study is ongoing, but not recruiting participants.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01588509
First received: April 17, 2012
Last updated: September 17, 2012
Last verified: September 2012
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Purpose
This is a phase 1, randomized, open-label, parallel group study conducted in healthy postmenopausal women with low bone mineral density previously treated with alendronate.
| Condition | Intervention | Phase |
|---|---|---|
|
OSTEOPOROSIS, POSTMENOPAUSAL |
Drug: AMG 785 Dose 1 Drug: AMG 785 Dose 2 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Change in lumbar spine bone mineral density (BMD) [ Time Frame: Change from baseline at day 85 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in total hip and femoral neck BMD [ Time Frame: Change from baseline at day 85 ] [ Designated as safety issue: No ]
- Change in serum type 1 aminoterminal propeptide (P1NP) measurements [ Time Frame: Change from baseline at day 85 ] [ Designated as safety issue: No ]
- Number of treatment-emergent adverse events to include clinically significant changes in chemistry, hematology, physical examinations, electrocardiograms, and incidences of subjects who develop anti-AMG 785 antibodies [ Time Frame: Up to day 85 ] [ Designated as safety issue: Yes ]
- Mean (SD) serum concentration of AMG 785 [ Time Frame: Baseline through day 85 ] [ Designated as safety issue: No ]
- Change in serum C-telopeptide (sCTX) measurements [ Time Frame: Change from baseline at day 85 ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: AMG 785 Treatment A
30 subjects will receive 3 doses
|
Drug: AMG 785 Dose 1
3 doses
|
|
Active Comparator: AMG 785 Treatment B
30 subjects will receive 3 doses
|
Drug: AMG 785 Dose 2
3 doses
|
Eligibility| Ages Eligible for Study: | 55 Years to 85 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588509
Locations
| United States, Arizona | |
| Research Site | |
| Tucson, Arizona, United States, 85711 | |
| United States, California | |
| Research Site | |
| Walnut Creek, California, United States, 94598 | |
| United States, Georgia | |
| Research Site | |
| Gainesville, Georgia, United States, 30501 | |
| United States, Hawaii | |
| Research Site | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Maryland | |
| Research Site | |
| Bethesda, Maryland, United States, 20817 | |
| United States, New Mexico | |
| Research Site | |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, New York | |
| Research Site | |
| West Haverstraw, New York, United States, 10993 | |
| United States, Pennsylvania | |
| Research Site | |
| Wyomissing, Pennsylvania, United States, 19610 | |
| United States, Washington | |
| Research Site | |
| Seattle, Washington, United States, 98144 | |
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01588509 History of Changes |
| Other Study ID Numbers: | 20110253 |
| Study First Received: | April 17, 2012 |
| Last Updated: | September 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Amgen:
|
AMG 785, bone mineral density, alendronate |
Additional relevant MeSH terms:
|
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
Alendronate Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013