Title: Denosumab Treatment in Postmenopausal Women with Osteoporosis Does Not Interfere with Fracture-Healing: Results from the FREEDOM Trial
Authors: Adami, Silvano ×
Libanati, Cesar
Boonen, Steven
Cummings, Steven R
Ho, Pei-Ran
Wang, Andrea
Siris, Ethel
Lane, Joseph
the FREEDOM Fracture-Healing Writing Group #
Issue Date: Dec-2012
Publisher: Journal of Bone and Joint Surgery
Series Title: Journal of Bone and Joint Surgery. American Volume vol:94 issue:23 pages:2113-2119
Article number: 10.2106/JBJS.K.00774
Abstract: BACKGROUND: Fracture is the major complication of osteoporosis, and it allows the identification of individuals needing medical intervention for osteoporosis. After nonvertebral fracture, patients often do not receive osteoporosis medical treatment despite evidence that this treatment reduces the risk of subsequent fracture. In this preplanned analysis of the results of the three-year, placebo-controlled FREEDOM trial, we evaluated the effect of denosumab administration on fracture-healing to address theoretical concerns related to initiating or continuing denosumab therapy in patients presenting with a nonvertebral fracture. METHODS: Postmenopausal women aged sixty to ninety years with osteoporosis were randomized to receive 60 mg of denosumab (n = 3902) or a placebo (n = 3906) subcutaneously every six months for three years. Investigators reported complications associated with a fracture or its management and with fracture-healing for all nonvertebral fractures that occurred during the study. Delayed healing was defined as incomplete fracture-healing six months after the fracture. RESULTS: Six hundred and sixty-seven subjects (303 treated with denosumab and 364 who received a placebo) had a total of 851 nonvertebral fractures (386 in the denosumab group and 465 in the placebo group), including 199 fractures (seventy-nine in the denosumab group and 120 in the placebo group) that were treated surgically. Delayed healing was reported in seven subjects (two in the denosumab group and five in the placebo group), including one with subsequent nonunion (in the placebo group). Neither delayed healing nor nonunion was observed in any subject who had received denosumab within six weeks preceding or following the fracture. A complication associated with the fracture or intervention occurred in five subjects (2%) and twenty subjects (5%) in the denosumab and placebo groups, respectively (p = 0.009). CONCLUSIONS: Denosumab in a dose of 60 mg every six months does not seem to delay fracture-healing or contribute to other complications, even when it is administered at or near the time of the fracture. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
ISSN: 0021-9355
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Gerontology and Geriatrics
× corresponding author
# (joint) last author

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