title: Denosumab significantly increases DXA BMD at both trabecular and cortical sites: results from the FREEDOM study.
abstract: Denosumab is an approved therapy for postmenopausal women with osteoporosis at high or increased risk for fracture. In the FREEDOM study, denosumab reduced fracture risk and increased bone mineral density (BMD). We report the spine and hip dual-energy X-ray absorptiometry (DXA) BMD responses from the overall study of 7808 women and from a substudy of 441 participants in which more extensive spine and hip assessments as well as additional skeletal sites were evaluated. Significant BMD improvements were observed as early as 1 mo at the lumbar spine, total hip, and trochanter (all p<0.005 vs placebo and baseline). BMD increased progressively at the lumbar spine, total hip, femoral neck, trochanter, 1/3 radius, and total body from baseline to months 12, 24, and 36 (all p<0.005 vs placebo and baseline). BMD gains above the least significant change of more than 3% at 36 months were observed in 90% of denosumab-treated subjects at the lumbar spine and 74% at the total hip, and gains more than 6% occurred in 77% and 38%, respectively. In conclusion, denosumab treatment resulted in significant, early, and continued BMD increases at both trabecular and cortical sites throughout the skeleton over 36 mo with important gains observed in most subjects.
authors.affiliation: The Bethesda Health Research Center, Bethesda, MD 20817, USA. mbolognese@erols.com
authors.forename: Michael A
authors.initials: MA
authors.lastname: Bolognese
authors.forename: Christence Stubbe
authors.initials: CS
authors.lastname: Teglbjærg
authors.forename: Jose R
authors.initials: JR
authors.lastname: Zanchetta
authors.forename: Kurt
authors.initials: K
authors.lastname: Lippuner
authors.forename: Michael R
authors.initials: MR
authors.lastname: McClung
authors.forename: Maria Luisa
authors.initials: ML
authors.lastname: Brandi
authors.forename: Arne
authors.initials: A
authors.lastname: Høiseth
authors.forename: Péter
authors.initials: P
authors.lastname: Lakatos
authors.forename: Alfred H
authors.initials: AH
authors.lastname: Moffett
authors.forename: Roman S
authors.initials: RS
authors.lastname: Lorenc
authors.forename: Andrea
authors.initials: A
authors.lastname: Wang
authors.forename: Cesar
authors.initials: C
authors.lastname: Libanati
mesh_terms: D015502:Absorptiometry, Photon; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000494:pharmacology* / Q000627:therapeutic use; D015519:Bone Density / Q000187:drug effects* / Q000502:physiology; D000069448:Denosumab; D005260:Female; D005272:Femur Neck / Q000502:physiology; D006801:Humans; D008159:Lumbar Vertebrae / Q000502:physiology; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D058866:Osteoporotic Fractures / Q000517:prevention & control; D053245:RANK Ligand / Q000037:antagonists & inhibitors*
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D053245:RANK Ligand; D000069448:Denosumab