| September 17, 2004 |
| November 23, 2009 |
| August 2004 |
| February 2009 (final data collection date for primary outcome measure) |
| The primary efficacy endpoint is the percent change from baseline in the lumbar spine BMD at 24 months of treatment. [ Time Frame: 24 Months ] [ Designated as safety issue: No ] |
| Percent change from baseline in the lumbar spine BMD after 24 month of treatment |
| Complete list of historical versions of study NCT00091793 on ClinicalTrials.gov Archive Site |
- The secondary efficacy endpoints include the following: Percent change from baseline in BMD of the total hip, femoral neck, trochanter, distal 1/3 radius, and total body at 24 months [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
- Percent change from baseline in trabecular, cortical, and total volumetric BMD of the distal radius as measured by QCT at 24 months [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
- Safety endpoints include the following: Adverse event incidence by system organ class and preferred term during the first month 24 and over the entire 48 month [ Time Frame: 48 Months ] [ Designated as safety issue: Yes ]
- Safety laboratory analytes (serum chemistry, hematology) at each visit and shifts between baseline and the worst on-study value [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]
- Subject incidence of anti-denosumab antibody appearance (Negative/Positive) during the first 24 months [ Time Frame: 48 months ] [ Designated as safety issue: No ]
- Changes in vital signs [ Time Frame: 48 months ] [ Designated as safety issue: No ]
- Changes from baseline at each visit and shifts between baseline and the most extreme on-study QTc interval and other intervals as deemed appropriate, and incidence of clinically significant abnormal ECG results [ Time Frame: 48 months ] [ Designated as safety issue: No ]
|
| Characterize the safety and tolerability of AMG 162 in this patient population |
| |
| Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis |
| A Randomized, Double-Blind Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis |
This study will determine whether treatment with AMG 162 can prevent lumbar spine bone loss in both early and late postmenopausal women with osteopenia, and to further test the safety and tolerability of AMG 162 in this population. |
| |
| Phase III |
| Interventional |
| Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Postmenopausal Osteoporosis |
- Drug: AMG 162
- Drug: Placebo
|
- Experimental: 60 mg/mL denosumab given day 1, month 6, month 12 and month 18
- Placebo Comparator: Placebo given day 1, month 6, month 12 and month 18
|
- Bone HG, Bolognese MA, Yuen CK, Kendler DL, Wang H, Liu Y, San Martin J. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women. J Clin Endocrinol Metab. 2008 Jun;93(6):2149-57. Epub 2008 Apr 1.
- Engelke K, Libanati C, Liu Y, Wang H, Austin M, Fuerst T, Stampa B, Timm W, Genant HK. Quantitative computed tomography (QCT) of the forearm using general purpose spiral whole-body CT scanners: accuracy, precision and comparison with dual-energy X-ray absorptiometry (DXA). Bone. 2009 Jul;45(1):110-8. Epub 2009 Apr 2.
|
| |
| Completed |
| 332 |
| March 2009 |
| February 2009 (final data collection date for primary outcome measure) |
Eligibility Criteria: - Postmenopausal women with Osteopenia (lumbar spine bone mineral density [BMD] T-score between 1.0 and -2.5) |
| Female |
| up to 90 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00091793 |
| Global Development Leader, Amgen Inc. |
| 20040132 |
| Amgen |
|
|
|
| Amgen |
| November 2009 |
