Phase 3
N=200
An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density
Low Bone Mineral Density
Bottom Line
View on ClinicalTrials.gov: NCT00325468 ↗Enrolled (actual)
200
Serious AEs
22.5%
Results posted
Jul 2013
Primary outcome: Primary: Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8 — 8.4; 11.2; 11.0; 16.5 percent
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AMG 162 (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Amgen
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8 |
8.4; 11.2; 11.0; 16.5; 12.4 | — |
| PRIMARY Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8 |
1.1; 4.3; 2.3; 6.8; 3.4 | — |
| PRIMARY Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8 |
-5.2; 1.4; 0.6; 1.3; -2.2 | — |
| SECONDARY Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8 |
-55.8; -44.7; -52.5; -44.4; -54.2 | — |
| SECONDARY Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8 |
-66.4; -72.0; -48.0; -64.6; -49.8 | — |
Summary
An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women with Low Bone Mineral Density
Eligibility Criteria
Inclusion Criteria
- Subject must be ambulatory
- Subject must have atteneded the 20010223 end-of-study visit and have completed all tests and procedures during the end-of-study visit
- signed informed consent must be obtained before any study-specific procedures
Exclusion Criteria
- Experienced severe and/or serious adverse event which were thought to be related to denosumab administration during the 20010223 study.
- Developed grade 3 or 4 laboratory abnormalities based on Common Terminology Criteria for Adverse Events v3.0 during the 20010223 study which did not normalized upon follow up or did not have diagnosis or treatment.
- Newly diagnosed conditions such as hyper/hypo thyroidism, rheumatoid arthritis, other bone diseases, renal disease.
- Using therapies while participating in the 20010223 study such as oral bisphosphonates, calcitonin, oral strontium, SERMS, systemic glucocortiocosteriods.
Data sourced from ClinicalTrials.gov (NCT00325468). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.