INDICATIONS AND USAGE

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.

In US women, rates of serious fractures have been increasing
A 2019 retrospective analysis demonstrated that, as of 2017, fracture rates were increasing.1
In women, rates of low-trauma fractures surpass stroke, MI, and breast cancer
combinedAnnual incidence of common illnesses in US women2-4
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
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.

Across a variety of health settings, rates of osteoporosis diagnosis and treatment
are lowCommercial 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:mass testing

pharmacotherapy


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

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
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)

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

Patient B
Aged 74
Distal radius
aBMD: 0.3 g/cm2

aBMD=areal bone mineral density.

Orthopedic groups have an opportunity to play an important role in managing
patients with postmenopausal osteoporosisThe AAOS has outlined objectives in care for patients with low-trauma fractures13:
AAOS=American Academy of Orthopaedic Surgeons.

In the wake of a fracture, timely intervention is critical
The 2020 AACE/ACE Clinical Practice Guidelines recommend that physicians14:
Appropriately diagnose osteoporosis in patients with fractures
Fracture alone is sufficient for a clinical diagnosis of PMOP.
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.
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:- A recent fracture (within the past 12 months)
- Fractures while on approved osteoporosis therapy
- Multiple fractures
AACE=American Association of Clinical Endocrinology; ACE=American College of Endocrinology; PMOP=postmenopausal osteoporosis.