INDICATIONS AND USAGE

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TYMLOS is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, TYMLOS reduces the risk of vertebral fractures and nonvertebral fractures.

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In US women, rates of serious fractures have been increasing

A 2019 retrospective analysis demonstrated that, as of 2017, fracture rates were increasing.1

Prevalence of osteoporotic fractures
Minus

In women, rates of low-trauma fractures surpass stroke, MI, and breast cancer
combined

Annual incidence of common illnesses in US women2-4

Chart showing annual incidence of common illnesses in US women
Chart showing annual incidence of common illnesses in US women

A 2015 study of a subset of US women receiving Medicare found that an estimated 970,000 women had ≥1 osteoporosis-related fracture.1

Annual incidence of fractures in US women

Privately insured and Medicare recipients aged ≥65 years

A 2019 retrospective analysis demonstrated that, as of 2017, fracture rates were increasing1

  • In women ≥65 years of age, fracture rates plateaued between 2013 and 2016, following a steady decline
  • As of 2017, fracture rates increased

Chart showing fracture rate per 1000 persons per year
Chart showing fracture rate per 1000 persons per year

This study further broke down the fracture rate by fracture site.1

  • Vertebral fractures were most common and demonstrated the most pronounced increase from 2014 through mid-2017
  • This analysis expands on previously published data, demonstrating that hip fracture incidence rates plateaued from 2012 to 20156
  • The study examined US fracture trends in commercially insured and Medicare Advantage health plan enrollees ≥50 years of age from 2007 to May 20171
  • Fractures of the ankle, carpal/wrist, hip, femur, pelvis, radius/ulna, shoulder, spine, tibia/fibula, or multiple sites were included1

MI=myocardial infarction.

Low rates of osteoporosis diagnosis and treatment
Plus

Across a variety of health settings, rates of osteoporosis diagnosis and treatment
are low

Commercial or Medicare payors*

A national sample of women ≥50 years of age (n=8349, 49+, fracture between 2008-2018) in the year following hip fracture
found that7:

~18%
Underwent bone
mass testing
Infographic showing rates of women who underwent bone mass testing, pharmacotherapy, and combination of both
~10%
Initiated
pharmacotherapy
Infographic showing rates of women who underwent bone mass testing, pharmacotherapy, and combination of both
~5%
Did both
Infographic showing rates of women who underwent bone mass testing, pharmacotherapy, and combination of both

~90% of these women did not receive any pharmacotherapy.

*A subset of patients had interactions with family medicine, internal medicine, or obstetrics and gynecology providers.
High risk for re-fracture
Plus

In a cross-sectional study of postmenopausal women, over 1 in 4 women with an initial fracture sustained a subsequent fracture, and the majority of those fractures occurred early8

n=4140, ages 50-80 years, study conducted between 1992-1994

Chart showing rate of refracture after initial fracture
Chart showing rate of refracture after initial fracture

A prior fracture is a strong predictor of future fracture in postmenopausal women9

Fractures of the wrist, spine, and hip have been shown to constitute ~40% of all osteoporosis-related fractures.*

Wrist fracture

  • Most common initial fracture
  • Associated with up to 1.8× increased risk for future fractures (non-weight-bearing bone)

Vertebral fracture

  • Most likely fracture to lead to a future fracture
  • Associated with up to 7.3× increased risk for future fractures (spine)

Hip fracture

  • Associated with up to 3.5× increased risk for future fractures (hip)
*Data derived from the Global Longitudinal Study of Osteoporosis in Women (aged ≥55 years).
Compromised bone strength
Plus

Compromised bone strength may lead to low-trauma fracture10

Bone strength = bone mineral density (BMD) + bone quality11

Microarchitecture can vary in postmenopausal women with similar BMD12*†

Patient A

Aged 74

Distal radius
aBMD: 0.3 g/cm2

Images of different microarchitecture in postmenopausal women with similar BMD

Patient B

Aged 74

Distal radius
aBMD: 0.3 g/cm2

Images of different microarchitecture in postmenopausal women with similar BMD
*Representative 3D reconstructions of HR-pQCT images of distal radius from a woman with a previous wrist fracture (right) and her age-matched control
without fracture (left). Their aBMD values were, respectively, 0.309 g/cm2 and 0.316 g/cm2 at the ultradistal radius.11
A matched case-control, 13-year follow-up study of 101 women who sustained a fragility fracture and had measures of density and architecture at the distal
radius and tibia.11

aBMD=areal bone mineral density.

Supporting patients and bone health
Plus

Orthopedic groups have an opportunity to play an important role in managing
patients with postmenopausal osteoporosis

The AAOS has outlined objectives in care for patients with low-trauma fractures13:

Consider and evaluate osteoporosis as the underlying cause

Create partnerships and clinical pathways

Consider
osteoporosis as a predisposing factor

in patients with low-trauma fracture

Advise patients
on osteoporosis evaluation

and potential benefits of treatment

Determine whether osteoporosis is an underlying cause

of fracture (through evaluation or referral)

Establish
partnerships

that facilitate the evaluation and treatment of patients

Encourage clinical
pathways

that ensure optimal care is provided for patients

Consider and evaluate osteoporosis as the underlying cause

Consider osteoporosis as a predisposing factor

in patients with low-trauma fracture

Advise patients on osteoporosis evaluation

and potential benefits of treatment

Determine whether osteoporosis is an underlying cause

of fracture (through evaluation or referral)

Create partnerships and clinical pathways

Establish partnerships

that facilitate the evaluation and treatment of patients

Encourage clinical pathways

that ensure optimal care is provided for patients

AAOS=American Academy of Orthopaedic Surgeons.

AACE Guidelines
Plus

In the wake of a fracture, timely intervention is critical

The 2020 AACE/ACE Clinical Practice Guidelines recommend that physicians14:

1

Appropriately diagnose osteoporosis in patients with fractures

Fracture alone is sufficient for a clinical diagnosis of PMOP.

2

Recognize that fracture puts patients at very high, immediate risk

Women with PMOP and a fracture within the last 12 months are considered very high risk for future fractures.

3

Initiate appropriate treatment

Certain therapies should be considered as initial options for PMOP women who are at very high risk for fractures.

According to the 2020 AACE guidelines, abaloparatide may be considered as initial
therapy for patients who are postmenopausal and at very high fracture risk14*

Women with postmenopausal osteoporosis who have suffered a fracture are considered very high risk,
including:

  • checked circle
    A recent fracture (within the past 12 months)
  • checked circle
    Fractures while on approved osteoporosis therapy
  • checked circle
    Multiple fractures
*In addition to abaloparatide, the 2020 AACE/ACE guidelines indicate that denosumab, romosozumab, teriparatide, and zoledronate should be considered as
initial therapy for very high-risk patients.

AACE=American Association of Clinical Endocrinology; ACE=American College of Endocrinology; PMOP=postmenopausal osteoporosis.

References: 1. Lewiecki EM, Chastek B, Sundquist K, et al. Osteoporotic fracture trends in a population of US managed care enrollees from 2007 to 2017. Osteoporos Int. 2020;31(7):1299-1304. 2. Burge R, Dawson-Hughes B, Solomon DH, Wong JB, King A, Tosteson A. Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. J Bone Miner Res. 2007;22(3):465-475. 3. Virani SS, Alonso A, Benjamin EJ, et al. Heart disease and stroke statistics—2020 update: a report from the American Heart Association. Circulation. 2020;141(9):e139-e596. 4. Cancer stat facts: female breast cancer. National Cancer Institute website. http://seer.cancer.gov/statfacts/html/breast.html. Accessed September 17, 2021. 5. Bone Health and Osteoporosis Foundation. 2019 Medicare cost of osteoporotic fractures. Bone Health Policy Institute website. https://www.bonehealthpolicyinstitute.org/full-milliman-report. Accessed September 17, 2021. 6. Lewiecki EM, Wright NC, Curtis JR, et al. Hip fracture trends in the United States, 2002 to 2015. Osteoporos Int. 2018;29(3):717-722. 7. Gillespie CW, Morin PE. Osteoporosis-related health services utilization following first hip fracture among a cohort of privately-insured women in the United States, 2008-2014: an observational study. J Bone Miner Res. 2017;32(5):1052-1061. 8. van Geel TA, van Helden S, Geusens PP, Winkens B, Dinant GJ. Clinical subsequent fractures cluster in time after first fractures. Ann Rheum Dis. 2009;68(1):99-102. 9. Gehlbach S, Saag KG, Adachi JD, et al. Previous fractures at multiple sites increase the risk for subsequent fractures: the Global Longitudinal Study of Osteoporosis in Women. J Bone Miner Res. 2012;27(3):645-653. 10. Seeman E. Age- and menopause-related bone loss compromise cortical and trabecular microstructure. J Gerontol A Biol Sci Med Sci. 2013;68(10):1218-1225. 11. Tella SH, Gallagher JC. Prevention and treatment of postmenopausal osteoporosis. J Steroid Biochem Mol Biol. 2014;142:155-170. 12. Sornay-Rendu E, Boutroy S, Munoz F, Delmas PD. Alterations of cortical and trabecular architecture are associated with fractures in postmenopausal women, partially independent of decreased BMD measured by DXA: the OFELY study. J Bone Miner Res. 2007;22(3):425-433. 13. Bouxsein ML, Kaufman J, Tosi L, Cummings S, Lane J, Johnell O. Recommendations for optimal care of the fragility fracture patient to reduce the risk of future fracture. J Am Acad Orthop Surg. 2004;12(6):385-395. 14. Camacho PM, Petak SM, Binkley N, et al. American Association of Clinical Endocrinologists/American College of Endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis–2020 update. Endocr Pract. 2020;26(Suppl 1):1-46.