Phase 3
N=79
A High-resolution Peripheral Quantitative Computed Tomography Study in Postmenopausal Women Previously Treated With Denosumab
Low Bone Mass · Low Bone Mineral Density · Osteoporosis · Postmenopausal Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00890981 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcome: Primary: Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT — -5.5; -1.8 Percent change — p=0.0766
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- high-resolution peripheral quantitative computed tomography (HR-pQCT) (Procedure); Dual energy X-ray absorptiometry (DXA) (Procedure); Denosumab (Biological); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Amgen
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT |
-5.5; -1.8 | 0.0766 |
| SECONDARY Percent Change From the Parent Study Baseline in Total Bone Mineral Density (BMD) at the Distal Radius by HR-pQCT |
-1.2; 0.3 | 0.1648 |
| SECONDARY Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Radius by HR-pQCT |
-1.0; -0.0 | 0.0228 sig |
| SECONDARY Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Radius by HR-pQCT |
5.1; 5.9 | 0.6560 |
| SECONDARY Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Tibia by HR-pQCT |
-6.4; -4.6 | 0.0594 |
| SECONDARY Percent Change From the Parent Study Baseline in Total BMD at the Distal Tibia by HR-pQCT |
-1.6; 1.0 | 0.0032 sig |
| SECONDARY Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Tibia by HR-pQCT |
-1.0; -0.6 | 0.2897 |
| SECONDARY Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Tibia by HR-pQCT |
2.9; 6.8 | 0.0067 sig |
| SECONDARY Percent Change of Distal 1/3 Radius BMD From the Parent Study Baseline by DXA |
-2.0; 0.0 | 0.0184 sig |
| SECONDARY Percent Change of Ultradistal Radius BMD From the Parent Study Baseline by DXA |
-3.5; -1.9 | 0.0911 |
| SECONDARY Percent Change of Total Radius BMD From the Parent Study Baseline by DXA |
-3.0; -0.9 | 0.0035 sig |
| SECONDARY Actual Value of Serum Type I C-telopeptide |
0.6; 0.7 | 0.0591 |
| SECONDARY Actual Value of Procollagen Type 1 N-terminal Peptide |
49.8; 58.9 | 0.0079 sig |
Summary
To evaluate the combined effect of denosumab treatment and discontinuation on cortical thickness at the distal radius by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT). Participants randomized to either denosumab or placebo in the 20050179 (NCT00293813) study who completed that study (ie, attended an end of study visit) can be included in this study. At least 12 months should have elapsed since the patient's 20050179 end of study visit.
Eligibility Criteria
Inclusion Criteria
- Ambulatory, postmenopausal women
- Randomized to either denosumab or placebo in the 20050179 (NCT00293813) study and completed that study (ie, attended an end of study visit)
- At least 12 months have elapsed since their end of 20050179 study visit
- Provide signed informed consent
Exclusion Criteria
- Subjects who failed to receive both doses of denosumab (or SQ [subcutaneous] placebo) during the 20050179 study
- Subjects who were randomized to the alendronate arm during the 20050179 study
- Subjects diagnosed with any of the following conditions following completion of the 20050179 study:
- Hyperthyroidism
- Hyperparathyroidism
- Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma)
- Any condition that required chronic (greater than three months cumulative and greater than 5 mg/day) glucocorticoid therapy
- Other diseases which affect bone metabolism
- Self-reported alcohol or drug abuse within the previous 12 months
- Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
- Received any investigational product other than denosumab in two years before the screening visit.
- Received > 3 months (or equivalent) of osteoporosis treatment since having completed the 20050179 study.
- Current use of the following osteoporosis agents: bisphosphonates, calcitonin, fluoride, parathyroid hormone analogue, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable), strontium or tibolone.
- Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s) (other than Amgen trial 20080287), or subject is receiving other investigational agent(s).
Data sourced from ClinicalTrials.gov (NCT00890981). 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.