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Ruban Dhaliwal, MD,MPH – Assistant Professor of Medicine, SUNY Upstate Medical University

Bruce Mitlak, MD – Vice President, Clinical Development, Radius Health, Inc., Waltham, MAA

Lorraine Fitzpatrick, MD – Chief Medical Officer Emeritus, Radius Health, Inc.

Yamei Wang, PhD – Senior Director, Biostatistics, Radius Health, Inc., Waltham, MA

Ann Schwartz, PhD, MPH – Associate Professor, UCSF School of Medicine, San Francisco, CA

Paul Miller, MD, FACP – Medical Director, Corado Center for Bone Research, Lakewood CO

Robert Josse, BSc, MBBS, FRCP, FRCPC, FACP, FACE – Professor of Medicine, Saint Michael’s Hospital, Toronto, ON, Canada


Objective :

In the ACTIVE phase 3 study (NCT01343004), 18 months (M) of abaloparatide (ABL) treatment significantly increased bone mineral density (BMD) and reduced the risk of new vertebral, nonvertebral, clinical, and major osteoporotic fractures vs placebo (PBO); findings were generally consistent in a post hoc analysis of women with type 2 diabetes mellitus (T2DM) in ACTIVE. Women receiving ABL or PBO in ACTIVE were offered enrollment in the ACTIVExtend extension study in which both groups received 24M open-label alendronate (ALN) 70 mg weekly for a total of 43M (18M ABL or PBO, 1M for reconsent, and 24M ALN). The objective of this post hoc analysis was to evaluate the efficacy of ABL followed by ALN (ABL/ALN) vs PBO/ALN in the subgroup of patients with T2DM.

Methods : A total of 1,139 patients (558, ABL/ALN and 581, PBO/ALN) were enrolled in ACTIVExtend. Patients with T2DM were identified by review of medical history records.  Prespecified endpoints including BMD, new vertebral, nonvertebral, clinical, and major osteoporotic fractures were assessed over the 43M period. New vertebral fracture incidence was evaluated using the mITT population, other endpoints were evaluated using the ITT population.

Results :

A total of 125 patients with T2DM were identified (ABL/ALN n = 61, PBO/ALN n = 64) [median age: 70 years; range: 55-82 years; mean femoral neck (FN) T-score: -2.26]. At 43M, 0% of ABL/ALN and 3.2% of PBO/ALN patients experienced a new vertebral fracture (p = NS). Kaplan-Meier estimated incidence were 3.4% ABL/ALN and 10.1% PBO/ALN for nonvertebral, 6.7% ABL/ALN and 10.1% PBO/ALN for clinical, and 1.7% ABL/ALN and 6.9% PBO/ALN for major osteoporotic fractures (p = NS, all comparisons). At 43 months, significant (p < 0.0001) increases in BMD from baseline were observed for ABL/ALN vs PBO/ALN at the total hip (mean change 6.3% vs 1.7%), femoral neck (4.7% vs 1.0%), and lumbar spine (15.9% vs 6.9%).

Discussion : Among the subgroup of women with osteoporosis and T2DM in ACTIVExtend, ABL followed by ALN resulted in numerical reductions in the risk of vertebral, nonvertebral, clinical, and major osteoporotic fractures, and significant improvements in BMD compared with PBO followed by ALN. Results are consistent with those previously reported in the overall ACTIVExtend population.

Conclusion : This post hoc analysis suggests that ABL followed by ALN may provide a valuable treatment sequence for women with postmenopausal osteoporosis and T2DM at high risk for fracture.

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