Abaloparatide is an anabolic, but does it spare resorption?

Journal article


Martin, T. John and Seeman, Ego. (2017). Abaloparatide is an anabolic, but does it spare resorption? Journal of Bone and Mineral Research. 32(1), pp. 11 - 16. https://doi.org/10.1001/jama.2016.11136
AuthorsMartin, T. John and Seeman, Ego
Abstract

Importance: Additional therapies are needed for prevention of osteoporotic fractures. Abaloparatide is a selective activator of the parathyroid hormone type 1 receptor. Objective: To determine the efficacy and safety of abaloparatide, 80 μg, vs placebo for prevention of new vertebral fracture in postmenopausal women at risk of osteoporotic fracture. Design, Setting, and Participants: The Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE) was a phase 3, double-blind, RCT (March 2011-October 2014) at 28 sites in 10 countries. Postmenopausal women with bone mineral density (BMD) T score ≤−2.5 and > −5.0 at the lumbar spine or femoral neck and radiological evidence ≥2 mild or ≥1 moderate lumbar or thoracic vertebral fracture or history of low-trauma nonvertebral fracture within the past 5 years were eligible. Postmenopausal women ( > 65 y) with fracture criteria and a T score ≤−2.0 and > −5.0 or without fracture criteria and a T score ≤−3.0 and > −5.0 could enroll. Interventions: Blinded, daily subcutaneous injections of placebo (n = 821); abaloparatide, 80 μg (n = 824); or open-label teriparatide, 20 μg (n = 818) for 18 months. Main Outcomes and Measures: Primary end point was percentage of participants with new vertebral fracture in the abaloparatide vs placebo groups. Sample size was set to detect a 4% difference (57% risk reduction) between treatment groups. Secondary end points included change in BMD at total hip, femoral neck, and lumbar spine in abaloparatide-treated vs placebo participants and time to first incident nonvertebral fracture. Hypercalcemia was a prespecified safety end point in abaloparatide-treated vs teriparatide participants. Results: Among 2463 women (mean age, 69 years [range, 49-86]), 1901 completed the study. New morphometric vertebral fractures occurred in 0.58% (n = 4) of the abaloparatide group, 4.22% (n = 30) of the placebo group (risk difference [RD] vs placebo, −3.64 [95% CI, −5.42 to −2.10]; relative risk, 0.14 [95% CI, 0.05-0.39]; P  <  .001), and 0.84% (n = 6) of the teriparatide group. The Kaplan-Meier estimated event rate for nonvertebral fracture was 2.7% for abaloparatide, 4.7% for placebo (RD, −2.01 [95% CI, −4.02 to −0.00]; hazard ratio [HR], 0.57 [95% CI, 0.32-1.00]; P = .049), and 3.3% for teriparatide. BMD increases were greater with abaloparatide than with placebo (all P  <  .001). Incidence of hypercalcemia was lower with abaloparatide (3.4%) than with teriparatide (6.4%) with an RD of −2.96 (95% CI, −5.12 to −0.87; P = .006). Conclusions and Relevance: Among postmenopausal women with osteoporosis, the use of subcutaneous abaloparatide, compared with placebo, reduced the risk of new vertebral and nonvertebral fractures over 18 months. Further research is needed to understand the clinical importance of RD, the risks and benefits of abaloparatide treatment, and the efficacy of abaloparatide vs other osteoporosis treatments. Trial Registration: clinicaltrials.gov Identifier: NCT01343004

Year2017
JournalJournal of Bone and Mineral Research
Journal citation32 (1), pp. 11 - 16
PublisherWiley-Blackwell Publishing, Inc.
ISSN0884-0431
Digital Object Identifier (DOI)https://doi.org/10.1001/jama.2016.11136
Scopus EID2-s2.0-85006827140
Page range11 - 16
Research GroupInstitute for Health and Ageing
Publisher's version
File Access Level
Controlled
Place of publicationUnited States
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Perilli, Egon, Bala, Yohann, Zebaze, Roger M., Reynolds, Karen J. and Seeman, Ego. (2015). Regional heterogeneity in the configuration of the intracortical canals of the femoral shaft. Calcified Tissue International. 97(4), pp. 327 - 335. https://doi.org/10.1007/s00223-015-0014-5
Changes in quality of life associated with fragility fractures : Australian arm of the International Cost and Utility Related to Osteoporotic Fractures Study (AusICUROS)
Abimanyi-Ochom, J., Watts, Jennifer, Borgstrom, F., Nicholson, Geoffrey, Shore-Lorenti, Catherine, Stuart, Amanda, Zhang, Y., Luliano, S., Seeman, Ego, Prince, Richard, March, Lyn, Winzenberg, T., Laslett, Laura, Duque, Gustavo, Ebeling, P. and Sanders, K. M.. (2015). Changes in quality of life associated with fragility fractures : Australian arm of the International Cost and Utility Related to Osteoporotic Fractures Study (AusICUROS). Osteoporosis International. 26(6), pp. 1781 - 1790. https://doi.org/10.1007/s00198-015-3088-z
Genetic and environmental variances of bone microarchitecture and bone remodeling markers: A twin study
Bjornerem, Ashild, Bui, Q Minh, Wang, Xiaofang, Ghasem-Zadeh, Ali, Hopper, John L., Zebaze, Roger M. and Seeman, Ego. (2015). Genetic and environmental variances of bone microarchitecture and bone remodeling markers: A twin study. Journal of Bone and Mineral Research. 30(3), pp. 516 - 524. https://doi.org/10.1002/jbmr.2365
Bones material constituents and their contribution to bone strength in health, disease, and treatment
Bala, Y. and Seeman, Ego. (2015). Bones material constituents and their contribution to bone strength in health, disease, and treatment. Calcified Tissue International. 97(3), pp. 308 - 326. https://doi.org/10.1007/s00223-015-9971-y
A. Michael Parfitt: Enlightened scholar and revered mentor: May 10, 1930-May 18, 2015
Manolagas, Stavros C., Compston, Juliet, Rao, Sudhaker and Seeman, Ego. (2015). A. Michael Parfitt: Enlightened scholar and revered mentor: May 10, 1930-May 18, 2015. Journal of Bone and Mineral Research. 30(8), pp. 1349 - 1355. https://doi.org/10.1002/jbmr.2576
Co-administration of antiresorptive and anabolic agents: A missed opportunity
Seeman, Ego and Martin, T. John. (2015). Co-administration of antiresorptive and anabolic agents: A missed opportunity. Journal of Bone and Mineral Research. 30(5), pp. 753 - 764. https://doi.org/10.1002/jbmr.2496
The ABC of writing a grant proposal
Seeman, Ego. (2015). The ABC of writing a grant proposal. Osteoporosis International. 26(6), pp. 1665 - 1666. https://doi.org/10.1007/s00198-015-3085-2
Growth and age-related abnormalities in cortical structure and fracture risk
Seeman, Ego. (2015). Growth and age-related abnormalities in cortical structure and fracture risk. Endocrinology and Metabolism. 30(4), pp. 419 - 428. https://doi.org/10.3803/EnM.2015.30.4.419
High-resolution in vivo imaging of bone and joints: a window to microarchitecture
Geusens, P., Geusens, P., Chapurlat, Roland D., Chapurlat, Roland D., Schett, G., Ghasem-Zadeh, Ali, Ghasem-Zadeh, Ali, Seeman, Ego, De Jong, J. and Van Den Bergh, J.. (2014). High-resolution in vivo imaging of bone and joints: a window to microarchitecture. Nature Reviews Rheumatology. 10(5), pp. 304 - 313. https://doi.org/10.1038/nrrheum.2014.23
A new method of segmentation of compact-appearing, transitional and trabecular compartments and quantification of cortical porosity from high resolution peripheral quantitative computed tomographic images
Zebaze, Roger M., Ghasem-Zadeh, Ali, Mbala, A. and Seeman, Ego. (2013). A new method of segmentation of compact-appearing, transitional and trabecular compartments and quantification of cortical porosity from high resolution peripheral quantitative computed tomographic images. Bone. 54(1), pp. 8 - 20. https://doi.org/10.1016/j.bone.2013.01.007
Teriparatide improves bone quality and healing of atypical femoral fractures associated with bisphosphonate therapy
Chiang, Cherie Ying, Zebaze, Roger M.D., Ghasem-Zadeh, Ali, Iuliano-Burns, Sandra, Hardidge, Andrew and Seeman, Ego. (2013). Teriparatide improves bone quality and healing of atypical femoral fractures associated with bisphosphonate therapy. Bone. 52(1), pp. 360 - 365. https://doi.org/10.1016/j.bone.2012.10.006
Predictors of new and severe vertebral fractures: Results from the HoRIZoN Pivotal Fracture Trial
Wustrack, R., Seeman, Ego, Bucci-Rechtweg, C. and Burch, S.. (2012). Predictors of new and severe vertebral fractures: Results from the HoRIZoN Pivotal Fracture Trial. Osteoporosis International. 23(1), pp. 53 - 58. https://doi.org/10.1007/s00198-011-1664-4
The effect of acute exercise on undercarboxylated osteocalcin in obese men
Levinger, Itamar, Zebaze, Roger M., Jeru, G., Hare, David L., Selig, Steve and Seeman, Ego. (2011). The effect of acute exercise on undercarboxylated osteocalcin in obese men. Osteoporosis International. 22(5), pp. 1621 - 1626. https://doi.org/10.1007/s00198-010-1370-7
Teriparatide therapy for osteonecrosis of the jaw REPLY
Cheung, Ada S. and Seeman, Ego. (2011). Teriparatide therapy for osteonecrosis of the jaw REPLY. New England Journal of Medicine. 364, pp. 1081 - 1082. https://doi.org/10.1056/NEJMc1100730
Festschrift to honor Professor Pierre D. Delmas
Seeman, E., Lindsay, R. and Kanis, J. A.. (2009). Festschrift to honor Professor Pierre D. Delmas. Osteoporosis International. 20(Supplement 3), pp. S231 - S233. https://doi.org/10.1007/s00198-008-0811-z
Bone fragility in men - Where are we?
Seeman, Ego, Bianchi, Georges, Khosla, Sundeep, Kanis, John and Orwoll, E. (2006). Bone fragility in men - Where are we? Osteoporosis International. 17(11), pp. 1577 - 1583. https://doi.org/10.1007/s00198-006-0160-8