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An illustration of osteoporotic bone being repaired by construction workers.An illustration of osteoporotic bone being repaired by construction workers.

Rebuild bone.
Rebuild it with TYMLOS.

Change the trajectory of osteoporosis for your patients.1

For men and postmenopausal women with osteoporosis at high risk for fracture1
Find Clinically Meaningful ResultsGet Prescribing Resources

How TYMLOS rebuilds bone.1

An illustration of osteoporotic bone being repaired by construction workers.TYMLOS acts quickly to shift the balance during bone remodeling to favor bone formation.1-4

TYMLOS is a PTHrP(1–34) analog that acts as an agonist at the PTH1 receptor. It activates the cAMP signaling pathway, which triggers the remodeling process in favor of bone formation.1,5-8

The science of abaloparatide
Effect on bone turnover markers
Effects of TYMLOS on indices of bone
formation in open-label study

Watch the video to learn about abaloparatide's mechanism of action.1

Video is intended to be viewed on desktop. If viewing on a mobile device, video should be played in full screen landscape mode.

TYMLOS stimulates early increases in bone formation markers that remain elevated for the duration of therapy.1

Daily administration of TYMLOS to postmenopausal women with osteoporosis for 18 months increased the bone formation marker serum procollagen type I N=propeptide (sPINP) and the bone resorption marker serum collagen type I Npropeptide (sPINP) and the bone resorption marker serum collagen type I cross-linked C-telopeptide (sCTX). The increase in geometric mean sPINP levels peaked at Month 1 at 93% above baseline in postmenopausal women then decreased slowly over time to 45% above baseline at Month 18. The increase in geometric mean sCTX levels in postmenopausal women peaked at Month 3 at 26% above baseline then decreased to baseline levels by Month 18.Daily administration of TYMLOS to postmenopausal women with osteoporosis for 18 months increased the bone formation marker serum procollagen type I N=propeptide (sPINP) and the bone resorption marker serum collagen type I Npropeptide (sPINP) and the bone resorption marker serum collagen type I cross-linked C-telopeptide (sCTX). The increase in geometric mean sPINP levels peaked at Month 1 at 93% above baseline in postmenopausal women then decreased slowly over time to 45% above baseline at Month 18. The increase in geometric mean sCTX levels in postmenopausal women peaked at Month 3 at 26% above baseline then decreased to baseline levels by Month 18.
Daily administration of TYMLOS to men with osteoporosis for 12 months increased the bone formation marker sPINP and the bone resorption marker sCTX. The increase in geometric mean sPINP levels peaked at Month 1 at 133% above baseline in men then decreased slowly over time to 84% above baseline at Month 12. The increase in geometric mean sCTX levels in men peaked at Month 6 at 46% above baseline and was 35% above baseline by Month 12.Daily administration of TYMLOS to men with osteoporosis for 12 months increased the bone formation marker sPINP and the bone resorption marker sCTX. The increase in geometric mean sPINP levels peaked at Month 1 at 133% above baseline in men then decreased slowly over time to 84% above baseline at Month 12. The increase in geometric mean sCTX levels in men peaked at Month 6 at 46% above baseline and was 35% above baseline by Month 12.

Mineralizing surface increase at 3 months†2

At baseline, median MS/BS was less than 10% of total surface on all bone envelopes (4.5% for trabecular bone, 9.4% for endocortical, 7.8% for intracortical, and 1.3% for periosteal surfaces) (Fig. 2A, Table 2). Median MS/BS increased to 24.7% for trabecular bone, 48.7% for endocortical, 21.4% for intracortical, and 16.3% for periosteal surfaces after 3 months of abaloparatide treatment, representing a 5.5-fold increase in trabecular bone, 5.2-fold increase in endocortical, 2.8-fold increase in intracortical, and 12.9-fold increase in periosteal surfaces (p < .001 versus baseline for all).

Mechanism of action representations are not meant to imply clinical efficacy. No new safety signals were seen. Adverse events were similar to those seen in the ACTIVE trial.1,2

†3 months is the amount of time it takes bones to form and mineralize in healthy adults.2-4

Open-label study evaluating the effects of TYMLOS on indices of bone formation.2

STUDY DESIGN: Open-label, single-arm study that evaluated the effects of TYMLOS on indices of bone formation using transiliac bone biopsies in postmenopausal women with osteoporosis. 23 biopsies were included in the safety population; 19 biopsies were evaluable. Subjects received double fluorochrome labels before treatment and before biopsy collection at 3 months.

PRIMARY ENDPOINT: Change in the mineralizing surface per unit of bone surface (MS/BS) in trabecular bone, from baseline to 3 months.

SECONDARY ENDPOINTS:

  • MS/BS across cortical and periosteal surfaces2
  • Remodeling- and modeling-based bone formation2

INCLUSION CRITERIA:

  • Postmenopausal women with osteoporosis, aged 50-85 years2
  • BMD: T-score ≥-2.5 at the lumbar spine or hip (including femoral neck or total hip) OR BMD+Fracture History: T-score ≥-2.0 at the lumbar spine or hip and a recent (>5 years) low-trauma vertebral, forearm, humerus, sacral, pelvic, femoral, or tibial fracture2

EXCLUSION CRITERIA: Patients with unevaluable lumbar spine or hip BMD, a history of bone disorders, metabolic bone disease, malabsorption, cancer in the past 5 years, osteosarcoma at any time, or prior radiotherapy (besides radioiodine) were excluded. Patients with a known hypersensitivity to TYMLOS, those who received prior treatment with PTH or PTHrP, denosumab, or IV bisphosphonates, took medications that interfere with bone metabolism within 6 months, or received treatment with oral bisphosphonates within 3 years were not eligible for this study.2

STUDY LIMITATIONS2:

  • Consider open-label study limitations when interpreting results. This open-label study was not blinded. These results are not meant to imply fracture efficacy
  • Single-arm study with no placebo group comparison and included only Caucasian female participants
  • Since the study had no control arm, a quadruple labeling procedure was used for internal control, allowing for a baseline comparison of bone formation indices within the same sample
    • Data generated from bone biopsies are variable, between subjects, and between biopsies taken from the same subject
    • While significant changes in these parameters are unlikely after 3 months of treatment, this labeling procedure does limit the ability to evaluate the effect of treatment on bone microarchitectural endpoints
  • Transiliac bone biopsies may not precisely reflect changes in bone at weight-bearing sites

BMD=bone mineral density; cAMP=cyclic adenosine monophosphate; IV=intravenous; PTH1=parathyroid hormone 1; PTHrP=parathyroid hormone-related peptide; s-CTX=serum carboxy-terminal cross-linked telopeptide of type 1 collagen; s-P1NP=serum procollagen type 1 N-terminal propeptide.

Could your patients be at imminent risk for fracture?

HAVE A T-SCORE
OF -3.0 OR WORSE9

CONTINUE TO LOSE BONE ON BISPHOSPHONATES9-11

Patients may continue to lose bone mass and are at risk for fracture despite bisphosphonate therapy.10-11

IN WOMEN

According to a retrospective study of 7,435 women ≥50 years of age and adherent to oral bisphosphonates for ≥2 years11:

35%HAD A FRACTURE, DECREASING BMD, OR A LOW POSTTREATMENT T-SCORE ≤-2.511

Patients may continue to lose bone mass and are at risk for fracture despite bisphosphonate therapy.10-11

IN WOMEN

According to a retrospective study of 7,435 women ≥50 years of age and adherent to oral bisphosphonates for ≥2 years11:

35%HAD A FRACTURE, DECREASING BMD, OR A LOW POST TREATMENT T-SCORE ≤-2.511

Worsening BMD predicts risk for fracture.3

BMD and fracture risk show an overlapping trend in both males and females—for each point reduction in the T-score, the risk of fracture roughly doubles.12-14

Using TYMLOS as initial therapy for patients at high risk for fracture.1,9

The 2020 AACE Guidelines support the use of TYMLOS* as initial therapy for appropriate patients, such as those outlined above.1,9

*

In addition to abaloparatide, the 2020 AACE/ACE Guidelines indicate that denosumab, romosozumab, teriparatide, and zoledronate should also be considered as initial therapy for very high-risk patients as defined by very low T-score (<-3.0), fractures while on osteoporosis therapy, recent fracture (≤12 months), multiple fractures, fractures while on glucocorticoids, high risk of falls or history of injurious falls, very high fracture probability by FRAX® (eg, major osteoporosis fracture >30%, hip fracture >4.5%) or other validated fracture risk algorithm9

AACE/ACE=American Association of Clinical Endocrinologists/American College of Endocrinology; BMD=bone mineral density; FRAX=fracture risk assessment tool.

TYMLOS works by rebuilding the bone.

See how TYMLOS performed in clinical trials.1

Review Efficacy and Safety Data

Resources and support for you and your patients.

Assistance with treatment access, injection training, and more. We have you covered.

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IMPORTANT SAFETY INFORMATION

Contraindications: TYMLOS is contraindicated in patients with a history of systemic hypersensitivity to abaloparatide or to any component of the product formulation. Reactions have included anaphylaxis, dyspnea, and urticaria.

Risk of Osteosarcoma: It is unknown whether TYMLOS will cause osteosarcoma in humans. Osteosarcoma has been reported in patients treated with a PTH-analog in the post marketing setting; however, an increased risk of osteosarcoma has not been observed in observational studies in humans. There are limited data assessing the risk of osteosarcoma beyond 2 years of TYMLOS use. Avoid use of TYMLOS for patients at an increased baseline risk for osteosarcoma including patients with open epiphysis (pediatric and young adult patients); metabolic bone diseases other than osteoporosis, including Paget’s disease of the bone; bone metastases or a history of skeletal malignancies; prior external beam or implant radiation therapy involving the skeleton; or hereditary disorders predisposing to osteosarcoma.

Orthostatic Hypotension: Orthostatic hypotension may occur with TYMLOS, typically within 4 hours of injection. Associated symptoms may include dizziness, palpitations, tachycardia, or nausea, and may resolve by having the patient lie down. For the first several doses, TYMLOS should be administered where the patient can sit or lie down if necessary.

Hypercalcemia: TYMLOS may cause hypercalcemia. TYMLOS is not recommended in patients with pre-existing hypercalcemia or in patients who have an underlying hypercalcemic disorder, such as primary hyperparathyroidism, because of the possibility of exacerbating hypercalcemia.

Hypercalciuria and Urolithiasis: TYMLOS may cause hypercalciuria. It is unknown whether TYMLOS may exacerbate urolithiasis in patients with active or a history of urolithiasis. If active urolithiasis or pre-existing hypercalciuria is suspected, measurement of urinary calcium excretion should be considered.

Pregnancy and Lactation: TYMLOS is not indicated for use in females of reproductive potential.

Adverse Reactions:

  • The most common adverse reactions (incidence ≥2%) reported with TYMLOS in postmenopausal women with osteoporosis are hypercalciuria (11%), dizziness (10%), nausea (8%), headache (8%), palpitations (5%), fatigue (3%), upper abdominal pain (3%), and vertigo (2%).
  • The most common adverse reactions (incidence ≥2%) reported with TYMLOS in men with osteoporosis are injection site erythema (13%), dizziness (9%), arthralgia (7%), injection site swelling (7%), injection site pain (6%), contusion (3%), abdominal distention (3%), diarrhea (3%), nausea (3%), abdominal pain (2%), and bone pain (2%).

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 or 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.
  • treatment to increase bone density in men with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy.
Please see full Prescribing Information. (opens in a new tab)

IMPORTANT SAFETY INFORMATION

Contraindications: TYMLOS is contraindicated in patients with a history of systemic hypersensitivity to abaloparatide or to any component of the product formulation. Reactions have included anaphylaxis, dyspnea, and urticaria.

Risk of Osteosarcoma: It is unknown whether TYMLOS will cause osteosarcoma in humans. Osteosarcoma has been reported in patients treated with a PTH-analog in the post marketing setting; however, an increased risk of osteosarcoma has not been observed in observational studies in humans. There are limited data assessing the risk of osteosarcoma beyond 2 years of TYMLOS use. Avoid use of TYMLOS for patients at an increased baseline risk for osteosarcoma including patients with open epiphysis (pediatric and young adult patients); metabolic bone diseases other than osteoporosis, including Paget’s disease of the bone; bone metastases or a history of skeletal malignancies; prior external beam or implant radiation therapy involving the skeleton; or hereditary disorders predisposing to osteosarcoma.

Orthostatic Hypotension: Orthostatic hypotension may occur with TYMLOS, typically within 4 hours of injection. Associated symptoms may include dizziness, palpitations, tachycardia, or nausea, and may resolve by having the patient lie down. For the first several doses, TYMLOS should be administered where the patient can sit or lie down if necessary.

Hypercalcemia: TYMLOS may cause hypercalcemia. TYMLOS is not recommended in patients with pre-existing hypercalcemia or in patients who have an underlying hypercalcemic disorder, such as primary hyperparathyroidism, because of the possibility of exacerbating hypercalcemia.

Hypercalciuria and Urolithiasis: TYMLOS may cause hypercalciuria. It is unknown whether TYMLOS may exacerbate urolithiasis in patients with active or a history of urolithiasis. If active urolithiasis or pre-existing hypercalciuria is suspected, measurement of urinary calcium excretion should be considered.

Pregnancy and Lactation: TYMLOS is not indicated for use in females of reproductive potential.

Adverse Reactions:

  • The most common adverse reactions (incidence ≥2%) reported with TYMLOS in postmenopausal women with osteoporosis are hypercalciuria (11%), dizziness (10%), nausea (8%), headache (8%), palpitations (5%), fatigue (3%), upper abdominal pain (3%), and vertigo (2%).
  • The most common adverse reactions (incidence ≥2%) reported with TYMLOS in men with osteoporosis are injection site erythema (13%), dizziness (9%), arthralgia (7%), injection site swelling (7%), injection site pain (6%), contusion (3%), abdominal distention (3%), diarrhea (3%), nausea (3%), abdominal pain (2%), and bone pain (2%).

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 or 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.
  • treatment to increase bone density in men with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy.

Please see full Prescribing Information (opens in a new tab).

References: 1. TYMLOS. Prescribing information. Radius Health, Inc. 2. Dempster DW, Zhou H, Rao SD, et al. Early effects of abaloparatide on bone formation and resorption indices in postmenopausal women with osteoporosis. J Bone Miner Res. 2021;36(4):644-653. 3. Baron R, Hesse E. Update on bone anabolics in osteoporosis treatment: rationale, current status, and perspectives.J Clin Endocrinol Metab. 2012;97(2):311-325. 4. Eriksen EF. Cellular mechanisms of bone remodeling. Rev Endocr Metab Disord. 2010;11(4):219-227. 5. 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. Published correction appears in JAMA. 2017;317(4):442. 6. Tay D, Cremers S, Bilezikian JP. Optimal dosing and delivery of parathyroid hormone and its analogues for osteoporosis and hypoparathyroidism—translating the pharmacology. Br J Clin Pharmacol. 2018;84(2):252-267. 7. Hattersley G, Dean T, Corbin BA, Bahar H, Gardella TJ. Binding selectivity of abaloparatide for PTH-type-1-receptor conformations and effects on downstream signaling. Endocrinology. 2016;157(1):141-149. 8. Siddiqui JA, Partridge NC. Physiological bone remodeling: systemic regulation and growth factor involvement. Physiology (Bethesda). 2016;31(3):233-245. 9. 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. 10. Friedman J, Eslami M. Medical management of osteoporosis when bisphosphonates fail. Curr Transl Geriatr Exp Gerontol Rep. 2013;2:105-112. 11. Imel EA, Eckert G, Modi A, et al. Proportion of osteoporotic women remaining at risk for fracture despite adherence to oral bisphosphonates. Bone. 2016;83:267-275. 12. Department of Health and Human Services. Bone Health and Osteoporosis: A Report of the Surgeon General. US Department of Health and Human Services, Office of the Surgeon General; 2004. 13. Vescini F, Chiodini I, Falchetti A, et al. Management of osteoporosis in men: a narrative review. Int J Mol Sci. 2021;22(24):13640. 14. Lewis CE, Ewing SK, Taylor BC, et al. Predictors of non-spine fracture in elderly men: the MrOS study. J Bone Miner Res. 2007;22(2):211-219.