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Change the trajectory of
osteoporosis for your patients.1

Find Clinically Meaningful ResultsGet Prescribing Resources
Rebuild bone with TYMLOS campaign imagery. Construction workers fixing bone marrow in spine.
Find Clinically Meaningful ResultsGet Prescribing Resources

How TYMLOS rebuilds bone.1

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TYMLOS quickly shifts 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 quickly stimulates, then sustains, bone formation.1

Daily administration of TYMLOS to postmenopausal women with osteoporosis for 18​ months increased the bone formation marker serum procollagen type 1 N-terminal propeptide (s-P1NP) and the bone resorption marker serum corboxy-terminal cross-linked telopeptide of type 1 collagen (s-CTX). The increase in geometric mean s-P1NP levels peaked at Month 1 to 93% above baseline in postmenopausal women then decreased slowly over time to 45% above baseline at Month 18. The increase in geometric mean s-CTX levels in postmenopausal women peaked at Month 3 to 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 s-P1NP and the bone resorption marker s-CTX. The increase in geometric mean s-P1NP levels peaked at Month 1 to 133% above baseline in men then decreased slowly over time to 84% above baseline at Month 12. The increase in geometric mean s-CTX levels in men peaked at Month 6 to 46% above baseline and was 35% above baseline by Month 12.

Mineralizing surface increase at 3 months*2

Change in mineralizing surface to bone surface of 5% in trabecular bone at baseline (4.5%) and at 3 months (24.7%) representing a 500%+ increase in trabecular bone

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, prior radiotherapy (besides radioiodine), Cushing's disease, or hypo- or hyperparathyroidism 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.

Dr. Michael Lewiecki discusses how men are often overlooked when identifying and treating osteoporosis.

View the presentation below (viewing in full screen is recommended).

Your patients could be at imminent risk for fracture

AACE/ACE guidelines define patients at very high risk for fracture based on†9:

T-score
  • –3.0 or worse
Fracture
  • Recent (<1 year)
  • Multiple fractures
  • History of fracture while on osteoporosis treatment or drugs causing skeletal harm
High risk for falls
FRAX®

Very high fracture probability:

  • >30% major osteoporosis fracture
  • >4.5% hip fracture

In addition, patients unable to use antiresorptive therapy or those that experience progressive bone loss while on antiresorptive therapy remain at elevated risk.

†AACE/ACE Guidelines are intended for postmenopausal women with osteoporosis.

AACE=American Association Of Clinical Endocrinologists, ACE=American College Of Endocrinology.
FRAX=Fracture Risk Assessment Tool, used to estimate the risk of fracture in the next 10 years.
FRAX is a registered trademark of the World Health Organization Collaborating Centre for Metabolic Bone Diseases, University of Sheffield, UK.

AACE/ACE guidelines support the use of abaloparatide for appropriate patients

AACE/ACE guidelines recommend9:
Starting on an osteoanabolic

If patients have factors that put them at very high risk for fracture or are unable to take an antiresorptive

OR
Switching to an osteoanabolic

If patients on antiresorptive therapy experience progressive bone loss, a fracture, or treatment intolerance

Download the AACE Guidelines for Osteoanabolics (opens in a new tab)

Dr. David Dempster discusses TYMLOS as a treatment option for both men and postmenopausal women that rebuilds bone.

View the presentation below (viewing in full screen is recommended).

TYMLOS is self-administered and requires no refrigeration after first use.1

Store for up to 30 days without refrigeration at a temperature between 68°F and 77°F (20°C and 25°C).1

TYMLOS (abaloparatide) pen

See how TYMLOS performed in clinical trials

Resources and support for you and your patients

Let us assist you with injection training and more.

Need support or samples?

Let us know if you want to request samples or a visit from a TYMLOS representative or field reimbursement manager.

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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.