Novel Procedure Increases Femur Strength for at Least 5 Years in Women With Osteoporosis

By Jody Manning

DENVER -- September 12, 2017 -- Injection of AGN1 in the proximal femur during a minimally-invasive local procedure resulted in substantially increased femoral strength in simulated sideways fall and stance loading conditions in postmenopausal women with osteoporosis, according to a study presented here at the 2017 Annual Meeting of the American Society for Bone and Mineral Research (ASBMR).

In the study, 12 postmenopausal women with osteoporosis underwent injection of AGN1, a resorbable, triphasic calcium sulfate/calcium phosphate implant material in the left femur to stimulate bone regeneration, with the right femur serving as a control.

The mean bone mineral density T-score was -3.1 ± 0.5 in the treated hip and -3.0 ± 0.7 in the control hip.

Computed tomography (CT) scans taken prior to the procedure and at 12 and 24 weeks were analysed using the finite analysis method to estimate hip strength in simulated stance loading and sideways fall conditions. Researchers assumed either 100% (α = 1.0) or 30% (α = 0.30) of the new bone tissue performed as normal load-bearing bone.

At 12 and 24 weeks, femoral strength in sideways fall was significantly higher in the treated femur than the control femur (P < .05), regardless of assumed strength factor.

While increased femoral strength in stance loading in the control femur was higher when α = 0.30, it was only significantly higher when 100% of the new tissue was assumed to be normal load-bearing.

In addition to the 12- and 24-week analysis, 10 of the 12 women participating in the study had follow-up CT scans and analysis at 5 to 7 years. In these women, femur strength in sideways fall was 36.5% ± 14.5% higher in the treated femur than the control femur when α = 1.0 and 23.1% ± 14.6% higher when α = 0.30. He noted that 2 of the women were also taking bisphosphonates during the extension part of the study.

“The results of this study suggest injection of AGN1 at the proximal femur can substantially increase the femur strength of osteoporotic women soon after the procedure as well as long-term,” wrote Tony Keaveny, PhD, University of California, Berkeley, California, and colleagues in their presentation.

[Presentation title: FEA-Estimated Proximal Femur Strength Increases Through 5-7 Year Follow-Up in Osteoporotic Women Treated With a Local Osteo-Enhancement Procedure Involving Injection of a Resorbable, Triphasic Calcium-Based Implant Material. Abstract 1036]
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