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Abstract Number: 1875

Subject Characteristics and Changes in Bone Mineral Density After Transitioning from Denosumab to Alendronate in the Denosumab Adherence Preference Satisfaction (DAPS) Study

David Kendler1, Arkadi Chines 2, Patricia Clark 3, Peter R. Ebeling 4, Michael McClung 5, Yumie Rhee 6, Shuang Huang 2, Robert Kees Stad 7 and Nick Freemantle 8, 1University of British Columbia, Vancouver, BC, Canada, 2Amgen Inc., Thousand Oaks, CA, 3Hospital Infantil de Mexico Federico Gómez and National University of Mexico, Mexico City, Mexico, 4Monash University, Melbourne, Victoria, Australia, 5Oregon Osteoporosis Center, Portland, OR, 6Yonsei University College of Medicine, Seoul, Republic of Korea, 7Amgen Inc., Rotkreuz, Zug, Switzerland, 8University College London, London, England, United Kingdom

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: Bisphosphonates, bone density and osteoporosis, denosumab

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Session Information

Date: Monday, November 11, 2019

Title: 4M114: Osteoporosis & Metabolic Bone Disease – Basic & Clinical Science (1872–1877)

Session Type: ACR Abstract Session

Session Time: 4:30PM-6:00PM

Background/Purpose: There are limited data on patients transitioning from denosumab (DMAb) to bisphosphonates (BPs). The Denosumab Adherence Preference Satisfaction (DAPS) study (NCT00518531) reported that alendronate (ALN) could maintain the gains in bone mineral density (BMD) achieved with 1 year of DMAb treatment (Freemantle Osteoporos Int 2012). Here, we investigate relationships between subject characteristics and their BMD responses after transitioning from DMAb to ALN.

Methods: DAPS was a 24-month, open-label, randomized, cross-over study designed to compare adherence to 12 months of DMAb treatment (60 mg Q6M SC) with ALN (70 mg QW PO) in treatment-naïve postmenopausal women with a T-score ≤─2.0 to ≥─4.0 at the lumbar spine (LS), total hip (TH), or femoral neck (FN). BMD was measured at baseline and months (M) 12 and 24. Here we evaluate subjects transitioning from DMAb to ALN at M12. A 3% BMD least significant change threshold identified subjects who lost, maintained, or gained BMD from M12 to M24 (change ≤─3%, >─3% and < 3%, or ≥3%, respectively); baseline, M12, and M24 characteristics were summarized using descriptive statistics.

Results: Of 126 subjects randomized to DMAb, 115 (91%) transitioned to ALN at M12. At baseline, subjects had a mean age of 65 years and mean BMD T-scores of ─2.0, ─1.6, and –2.0 at the LS, TH, and FN, respectively. BMD increased by 5.6%, 3.2%, and 3.1% with DMAb from M0 to M12 at the LS, TH, and FN, respectively, and changed by 0.6%, 0.4%, and –0.1% with ALN from M12 to M24. After transitioning from DMAb to ALN, most subjects showed maintained or increased BMD (Table); 15.9%, 7.6%, and 21.7% lost BMD at the LS, TH, and FN, respectively, and only 1 subject (1.2%) lost BMD at all 3 sites. Baseline characteristics, M12 BMD, and adherence to oral ALN showed no trend with the BMD change from M12 to M24. However, subjects who lost BMD from M12 to M24 on ALN showed greater gains in BMD from M0 to M12 on DMAb, and few who lost BMD fell below their pre-study baseline BMD value. No subject experienced clinical vertebral fracture.

Conclusion: ALN can effectively maintain the BMD gains accrued after 1 year of DMAb in most subjects. Those with larger BMD increases in year 1 are more likely to lose BMD in year 2, with other subject characteristics not predictive of the response in year 2. These data highlight the need for oral BP therapy following DMAb cessation and BMD monitoring of patients transitioning from DMAb to ALN.

Selected baseline characteristics and percentage change in BMD for subjects who lost, maintained, or gained BMD after transitioning from denosumab to alendronate.


Disclosure: D. Kendler, Amgen Inc., 2, 5, 8, Eli Lilly, 2, 5, 8, Pfizer, 5; A. Chines, Amgen, 1, 3, Amgen Inc., 1, 3; P. Clark, Pfizer, 2, 8, Amgen Inc., 8, Eli Lilly, 8; P. Ebeling, Amgen Inc., 2, 5, Eli Lilly, 2, Alexion, 5; M. McClung, Amgen Inc., 5, 8; Y. Rhee, Amgen Inc., 2, 8; S. Huang, Amgen Inc., 1, 3; R. Kees Stad, Amgen Inc., 1, 3; N. Freemantle, Ipsen, 2, PTC, 2, Allergan, 2, Sanofi Aventis, 2, 8, Astra Zeneca, 5, 8, Ionis, 5.

To cite this abstract in AMA style:

Kendler D, Chines A, Clark P, Ebeling P, McClung M, Rhee Y, Huang S, Kees Stad R, Freemantle N. Subject Characteristics and Changes in Bone Mineral Density After Transitioning from Denosumab to Alendronate in the Denosumab Adherence Preference Satisfaction (DAPS) Study [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/subject-characteristics-and-changes-in-bone-mineral-density-after-transitioning-from-denosumab-to-alendronate-in-the-denosumab-adherence-preference-satisfaction-daps-study/. Accessed .
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