Format

Send to

Choose Destination
Bone. 2020 Feb 10;134:115268. doi: 10.1016/j.bone.2020.115268. [Epub ahead of print]

Denosumab in postmenopausal women with osteoporosis and diabetes: Subgroup analysis of FREEDOM and FREEDOM extension.

Author information

1
Division of Bone Diseases, Geneva University Hospitals, Geneva, Switzerland. Electronic address: Serge.Ferrari@unige.ch.
2
Academic unit of Bone Metabolism, University of Sheffield, Sheffield, UK.
3
John T. Milliken Department of Medicine, Campus Bio-Medico, University of Rome, Rome, Italy; Ospedale Galeazzi IRCCS, Milan, Italy.
4
School of Medicine, University of California San Francisco, San Francisco, CA, USA.
5
Center for Healthy Aging and Division of Endocrinology, Diabetes, and Bone Diseases, Technische Universität Dresden, Dresden, Germany.
6
Global Development, Amgen Inc., Thousand Oaks, CA, USA.
7
Global Biostatistical Science, Amgen Inc., Thousand Oaks, CA, USA.

Abstract

PURPOSE:

Diabetes and osteoporosis occur frequently in older adults and are both associated with increased fracture risk. Denosumab treatment reduced new vertebral, nonvertebral, and hip fractures over 3 years, with continued low fracture incidence for up to 10 years in postmenopausal women with osteoporosis. However, its effects in diabetic subjects with osteoporosis have not yet been investigated.

METHODS:

Post hoc analysis of the 3-year, placebo-controlled FREEDOM study and 7-year Extension included postmenopausal women with osteoporosis and diabetes. Effects on BMD, vertebral, and nonvertebral fracture incidence were evaluated.

RESULTS:

Of 7808 subjects in FREEDOM, 508 with diabetes received denosumab (n = 266) or placebo (n = 242). Among those, BMD increased significantly with denosumab versus placebo in FREEDOM, and continued to increase during the Extension in long-term (continuing denosumab) and crossover (placebo to denosumab) denosumab subjects. In FREEDOM, denosumab-treated subjects with diabetes had significantly lower new vertebral fracture rates (1.6%) versus placebo (8.0%) (RR: 0.20 [95% CI 0.07-0.61]; p = .001). Nonvertebral fracture incidence was higher with denosumab (11.7%) versus placebo (5.9%) (HR: 1.94 [95% CI 1.00-3.77]; p = .046), although there were fewer hip fractures with denosumab (World Health Organization, 2017 [1]) than placebo (4; nonsignificant). During the first 3 years in FREEDOM Extension, new vertebral and nonvertebral fracture incidences were low in long-term and crossover denosumab diabetic groups (≤6%), consistent with the overall Extension population; yearly nonvertebral fracture incidence was comparable to the FREEDOM placebo group.

CONCLUSION:

Denosumab significantly increased BMD and decreased vertebral fracture risk in subjects with osteoporosis and diabetes. No reduction in nonvertebral fractures was observed.

KEYWORDS:

Clinical trials; Diseases and disorders of/related to bone osteoporosis; Therapeutics antiresorptive

PMID:
32058020
DOI:
10.1016/j.bone.2020.115268
Free full text

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center