Active comparator data

TYMLOS (fracture incidence 0.6%) demonstrated significant reduction in the risk of new
vertebral fractures at 18 months versus placebo (fracture incidence 4.2%, P<0.0001)1

Study design

TYMLOS BMD results
TYMLOS BMD results

Primary endpoint: Incidence of new vertebral fractures1

Secondary endpoints2:

Incidence of nonvertebral fractures

Changes in BMD from baseline at the lumbar spine, total hip, and femoral neck

This study was not designed to provide head-to-head comparative efficacy data and
cannot be interpreted as evidence of superiority or noninferiority to teriparatide.2

Active comparator: new vertebral fracture results

This study was not designed to provide head-to-head comparative efficacy data and cannot be interpreted as evidence of superiority or noninferiority to teriparatide.2

Percentage of postmenopausal women with osteoporosis with new vertebral fractures at 18 months2

Adverse reactions reported by patients treated with TYMLOS vs placebo

P<0.001 versus placebo.2
Results reported in the modified ITT population, which included patients who had both pretreatment and posttreatment spine radiographs.2

See nonvertebral fracture data Minus iconPlus icon

Active comparator: nonvertebral fracture results

This study was not designed to provide head-to-head comparative efficacy data and cannot be interpreted as evidence of superiority or noninferiority to teriparatide.2

Cumulative incidence of nonvertebral fractures* at 19 months (18 months
of treatment plus 1 month of follow-up without treatment)2

Adverse reactions reported by patients treated with TYMLOS vs placebo

Nonvertebral fractures excluded those of the sternum, patella, toes, fingers, skull, and face, and those associated with high trauma.2

P=0.22 versus placebo.2

P-value based on the log-rank test.2

P=0.049 versus placebo.2
Results reported in ITT population, which included patients randomized in the efficacy study.2

See change in BMDMinus iconPlus icon

Active comparator: BMD results over time

This study was not designed to provide head-to-head comparative efficacy data and cannot be interpreted as evidence of superiority or noninferiority to teriparatide.2

Mean percent change from baseline in BMD in postmenopausal women with osteoporosis4

Adverse reactions reported by patients treated with TYMLOS vs placebo

P=0.0001 versus placebo.4

P<0.0001 versus teriparatide.4

TYMLOS versus placebo: BMD at 18 months was a secondary endpoint (comparisons at 6 and 12 months were exploratory endpoints).2
TYMLOS versus teriparatide: BMD at 6 months was a secondary endpoint (comparisons at 12 and 18 months were exploratory endpoints). Comparisons at the lumbar spine at all timepoints are exploratory.2,4
Results reported in ITT population, which included patients randomized in the efficacy study; mean percentage change in BMD was LOCF.2,4
Error bars indicate 95% confidence intervals.2
BMD captured with DXA scans.5

View continued efficacy
results with
TYMLOS
followed by alendronate

References: 1. TYMLOS® [prescribing information]. Waltham, MA: Radius Health, Inc; 2017. 2. Miller PD, Hattersley G, Riis BJ, et al. Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial. JAMA. 2016;316(7):722-733. [Erratum: JAMA. 2017;317(4):442.] 3. A randomized, double-blind, placebo-controlled, comparative phase 3 multicenter study to evaluate the safety and efficacy of BA058 for injection for prevention of fracture in ambulatory postmenopausal women with severe osteoporosis and at risk of fracture [supplement 1]. Waltham, MA: Radius Health, Inc; 2014. http://jamanetwork.com/data/Journals/JAMA/935644/JOI160092supp1_prod.pdf. Accessed April 3, 2018. 4. Data on file. Radius Health, Inc; Waltham, MA. 5. A randomized, double-blind, placebo-controlled, comparative phase 3 multicenter study to evaluate the safety and efficacy of BA058 for injection for prevention of fracture in ambulatory postmenopausal women with severe osteoporosis and at risk of fracture [supplement 2]. Waltham, MA: Radius Health, Inc; 2015. http://jamanetwork.com/data/Journals/JAMA/935644/JOI160092supp2_prod.pdf. Accessed April 3, 2018.

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All other trademarks are the property of their respective owners.

© 2018 Radius Health, Inc.   All rights reserved.    04/18.   TYM-US-01391

This site is intended for HCPs in the United States.
TYMLOS is a registered trademark of Radius Health, Inc.
All other trademarks are the property of their respective owners.

© 2018 Radius Health, Inc.
All rights reserved. 04/18.
TYM-US-01391

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