Back to Search
Start Over
Effect of denosumab on bone mineral density and biochemical markers of bone turnover: six-year results of a phase 2 clinical trial.
- Source :
-
The Journal of clinical endocrinology and metabolism [J Clin Endocrinol Metab] 2011 Feb; Vol. 96 (2), pp. 394-402. Date of Electronic Publication: 2010 Dec 15. - Publication Year :
- 2011
-
Abstract
- Context: This is a study extension to evaluate the efficacy and safety of long-term treatment with denosumab in postmenopausal women with low bone mass.<br />Objective: Our objective was to describe changes in bone mineral density (BMD) and bone turnover markers as well as safety with 6 yr of denosumab treatment.<br />Design: We conducted an ongoing 4-yr, open-label, single-arm, extension study of a dose-ranging phase 2 trial. This paper reports a 2-yr interim analysis representing up to 6 yr of continuous denosumab treatment.<br />Setting: This multicenter study was conducted at 23 U.S. centers.<br />Patients: Of the 262 subjects who completed the parent study, 200 enrolled in the study extension and 178 (89%) completed the first 2 yr.<br />Intervention: All subjects received denosumab 60 mg sc every 6 months.<br />Main Outcome Measures: We evaluated BMD at the lumbar spine, total hip, femoral neck, and one third radius; biochemical markers of bone turnover; and safety, reported as adverse events.<br />Results: Over a period of 6 yr, continuous treatment with denosumab resulted in progressive gains in BMD in postmenopausal women with low bone mass. Reduction in bone resorption was sustained over the course of continuous treatment. Independent of past treatment and discontinuation period, subjects demonstrated responsiveness to denosumab therapy as measured by BMD and bone turnover markers. The safety profile of denosumab did not change over time.<br />Conclusions: In this study, denosumab was well tolerated and effective through 6 yr of continuous treatment in postmenopausal women with low bone mass.
- Subjects :
- Aged
Aged, 80 and over
Alendronate therapeutic use
Alkaline Phosphatase blood
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal, Humanized
Biomarkers
Bone Density Conservation Agents adverse effects
Bone and Bones drug effects
Bone and Bones enzymology
Cohort Studies
Denosumab
Female
Hip diagnostic imaging
Humans
Middle Aged
Osteoporosis, Postmenopausal pathology
RANK Ligand adverse effects
RANK Ligand metabolism
Radiography
Radius diagnostic imaging
Spine diagnostic imaging
Antibodies, Monoclonal therapeutic use
Bone Density drug effects
Bone Density Conservation Agents therapeutic use
Bone and Bones metabolism
Osteoporosis, Postmenopausal drug therapy
RANK Ligand therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1945-7197
- Volume :
- 96
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- The Journal of clinical endocrinology and metabolism
- Publication Type :
- Academic Journal
- Accession number :
- 21159841
- Full Text :
- https://doi.org/10.1210/jc.2010-1805