- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
- Events & Workshops
Data show denosumab achieves greater bone mineral density gains
12 October 2015 • Author: Victoria White
Results from a Phase 4 study of Amgen’s Prolia (denosumab) showed that the drug achieved greater gains in bone mineral density (BMD) than intravenous bisphosphonate zoledronic acid in postmenopausal women with osteoporosis following previous treatment with oral bisphosphonates.
“Despite the availability of newer therapies like denosumab, bisphosphonates are commonly used first-line to treat osteoporosis,” said lead investigator Paul Miller, M.D., medical director of the Colorado Center for Bone Research, Lakewood, Colo. “Our findings showed that denosumab provides significantly greater bone mineral density increases than zoledronic acid.”
Patients treated with denosumab had significantly greater improvements in primary and secondary endpoints in the study
The 12-month study included 643 women 55 years or older who had postmenopausal osteoporosis and had been taking oral bisphosphonate therapy for two or more years. The women were randomized 1:1 to receive either subcutaneous denosumab every six months plus intravenous placebo once yearly or intravenous zoledronic acid once yearly plus subcutaneous placebo every six months. The change from baseline in lumbar spine BMD at 12 months – the primary endpoint – in the denosumab group was significantly greater than that in the zoledronic acid group.
The denosumab group also had significantly greater improvements than the zoledronic acid group in secondary and exploratory study endpoints, including BMD changes in the total hip, femoral neck, and 1/3 radius.
“These findings add to the evidence supporting Prolia as an important therapeutic option for women with postmenopausal osteoporosis, especially those who have failed bisphosphonate treatment,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Our continued research in this innovative antiresorptive reinforces Amgen’s commitment to bone biology and understanding the value Prolia brings to treating osteoporosis in postmenopausal women at high risk for fracture.”
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) EUROGENTEC F.P.S. Food and Pharma Systems Srl IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics