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When it's time to rebuild bone, it's time for TYMLOS.1

TYMLOS rebuilds a foundation of new bone and provides clinically meaningful fracture risk reduction.1

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ACTIVE Study DesignFracture Risk Reduction/BMD ResultsACTIVE Safety
ACTIVExtend Study DesignLong-Term Risk Reduction/BMD ResultsEfficacy and Safety in Men

TYMLOS efficacy was demonstrated in the ACTIVE trial.1,2

IN POSTMENOPAUSAL WOMEN

Study Design: A randomized, multicenter, double-blind, placebo- and active-controlled clinical study in postmenopausal women with osteoporosis (N=2,463) aged 49 to 86 years (mean age 69 years) who were randomized to receive TYMLOS 80 mcg (n=824), placebo (n=821), or teriparatide 20 mcg (n=818) subcutaneously once daily for 18 months.1,2

primary endpoint: Incidence of new vertebral fracture at 18 months (TYMLOS vs placebo).*1

SECONDARY endpoints:

  • Incidence of nonvertebral fractures at 18 months (TYMLOS vs placebo and TYMLOS vs teriparatide)†1,2
  • BMD change from baseline at the lumbar spine, total hip, and femoral neck at 18 months (TYMLOS vs placebo; comparisons at 6 and 12 months are exploratory)‡1,2
  • BMD change from baseline at the lumbar spine, total hip, and femoral neck, comparing teriparatide and TYMLOS at 6 months (comparisons at 12 and 18 months are exploratory)‡2

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.

  • *

    Modified ITT population, which includes patients who had both pretreatment and posttreatment spine radiographs.1

  • †

    Nonvertebral fractures were measured using the ITT population and excluded fractures of the sternum, patella, toes, fingers, skull, and face, and those associated with high trauma.1

  • ‡

    Results reported in the ITT population, which included patients randomized in the efficacy study; last observation carried forward.1,2

BMD=bone mineral density; ITT=intent-to-treat.

TYMLOS helps protect patients against fracture while on treatment.1

TYMLOS significantly reduces vertebral and nonvertebral fractures.1

The primary endpoint was the incidence of new vertebral fractures in patients treated with TYMLOS compared to placebo. TYMLOS resulted in a significant reduction in the incidence of new vertebral fractures compared to placebo at 18 months (0.6% TYMLOS compared to 4.2% placebo, p <0.0001). The absolute risk reduction in new vertebral fractures was 3.6% at 18 months and the relative risk reduction was 86% for TYMLOS compared to placebo. TYMLOS resulted in a significant reduction in the incidence of nonvertebral fractures at the end of the 18 months of treatment plus 1 month follow-up where no drug was administered (2.7% for TYMLOS-treated patients compared to 4.7% for placebo-treated patients). The relative risk reduction in nonvertebral fractures for TYMLOS compared to placebo was 43% (logrank test p = 0.049) and the absolute risk reduction was 2.0%.The primary endpoint was the incidence of new vertebral fractures in patients treated with TYMLOS compared to placebo. TYMLOS resulted in a significant reduction in the incidence of new vertebral fractures compared to placebo at 18 months (0.6% TYMLOS compared to 4.2% placebo, p <0.0001). The absolute risk reduction in new vertebral fractures was 3.6% at 18 months and the relative risk reduction was 86% for TYMLOS compared to placebo. TYMLOS resulted in a significant reduction in the incidence of nonvertebral fractures at the end of the 18 months of treatment plus 1 month follow-up where no drug was administered (2.7% for TYMLOS-treated patients compared to 4.7% for placebo-treated patients). The relative risk reduction in nonvertebral fractures for TYMLOS compared to placebo was 43% (logrank test p = 0.049) and the absolute risk reduction was 2.0%.

§Modified ITT population, which includes patients who had both pretreatment and posttreatment spine radiographs.
Nonvertebral fractures were measured using the ITT population at 19 months (the entire observational period included 18 months of treatment plus 1 month of follow-up). Nonvertebral fractures excluded fractures of the sternum, patella, toes, fingers, skull, and face, and those associated with high trauma.
#95% CI: 61, 95.
**95% CI: 2.1, 5.4.
††i P i value based on the log-rank test.

Jump to ACTIVExtend Study Design
The primary endpoint was the incidence of new vertebral fractures in patients treated with TYMLOS compared to placebo. TYMLOS resulted in a significant reduction in the incidence of new vertebral fractures compared to placebo at 18 months (0.6% TYMLOS compared to 4.2% placebo, p <0.0001). The absolute risk reduction in new vertebral fractures was 3.6% at 18 months and the relative risk reduction was 86% for TYMLOS compared to placebo. TYMLOS resulted in a significant reduction in the incidence of nonvertebral fractures at the end of the 18 months of treatment plus 1 month follow-up where no drug was administered (2.7% for TYMLOS-treated patients compared to 4.7% for placebo-treated patients). The relative risk reduction in nonvertebral fractures for TYMLOS compared to placebo was 43% (logrank test p = 0.049) and the absolute risk reduction was 2.0%.

§Modified ITT population, which includes patients who had both pretreatment and posttreatment spine radiographs.
95% CI: 61, 95.
#95% CI: 2.1, 5.4.
**Nonvertebral fractures were measured using the ITT population at 19 months (the entire observational period included 18 months of treatment plus 1 month of follow-up). Nonvertebral fractures excluded fractures of the sternum, patella, toes, fingers, skull, and face, and those associated with high trauma.
††P i value based on the log-rank test.

Jump to ACTIVExtend Study Design

TYMLOS helps patients build up significant BMD gains vs placebo and protects them against bone loss while on treatment.1-3

Treatment with TYMLOS for 18 months in Study 003 resulted in significant increases in BMD compared to placebo at the lumbar spine, total hip, and femoral neck, each with p<0.0001. Similar findings were seen following 6 months of alendronate treatment in Study 005.
Section OneSection TwoSection ThreeSection FourSection FiveSection SixSection Seven

‡‡Results reported in the ITT population, which included patients randomized in the efficacy study; last observation carried forward.1,2
§§Error bars indicate 95% confidence intervals.2,3
¶¶P >0.0001 vs placebo (secondary endpoint).3
##P >0.0001 vs teriparatide.3

ARR=absolute risk reduction;BMD=bone mineral density; CI=confidence interval;ITT=intent-to-treat.

Jump to ACTIVExtend Study Design

‡‡Results reported in the ITT population, which included patients randomized in the efficacy study; last observation carried forward.1,2
§§As a secondary endpoint, TYMLOS was also compared to teriparatide at 6 months.2,3
¶¶95% CI for TYMLOS (lumbar spine: 8.7, 9.7;total hip: 3.2, 3.7;femoral neck: 2.6, 3.2), for teriparatide(lumbar spine: 8.7, 9.5;total hip: 2.6, 3.0;femoral neck: 2.0, 2.5), and for placebo (lumbar spine: 0.2, 0.7;total hip: -0.3, 0.1;femoral neck: -0.7, -0.2). 3
##P >0.0001 vs placebo (secondary endpoint).3

ARR=absolute risk reduction; BMD=bone mineral density; CI=confidence interval; ITT=intent-to-treat.

Jump to ACTIVExtend Study Design

TYMLOS has a well-established safety profile.1,2,4,5

Adverse reactions were evaluated in 2,460 postmenopausal women with osteoporosis.**1,2

Table shows the most common adverse reactions in the trial. These adverse reactions were generally not present at baseline, occurred more commonly with TYMLOS than with placebo and occurred in at least 2% of the patients treated with TYMLOS.Table shows the most common adverse reactions in the trial. These adverse reactions were generally not present at baseline, occurred more commonly with TYMLOS than with placebo and occurred in at least 2% of the patients treated with TYMLOS.

***The safety analysis included an open-label, active comparative arm with teriparatide (n=818). This study was not designed to provide head-to-head comparative safety data and cannot be interpreted as evidence of superiority or noninferiority to teriparatide.2
†††Adverse reactions reported in ≥2% of TYMLOS-treated patients.1
‡‡‡Hypercalcemia was a prespecified safety endpoint, defined as albumin-corrected serum calcium of at least 10.7 mg/dL (2.67 mmol/L) at any time point.1,2

ACTIVE trial participants included patients with:

Efficacy was maintained with follow-on therapy in the ACTIVExtend trial.1,4,5

ACTIVExtend—long-term evaluation of TYMLOS efficacy followed with open-label alendronate.1

The extension study evaluated if the fracture risk reductions and increases in BMD achieved with TYMLOS could be maintained with follow-on therapy with alendronate.1,4,5

IN POSTMENOPAUSAL WOMEN

Extension Study Design: A 24-month, open-label, follow-up study of postmenopausal women who completed the 18-month ACTIVE trial and enrolled in the extension study where they transitioned to alendronate 70 mg weekly as follow-on maintenance therapy from either TYMLOS 80 mcg (n=558) or placebo (n=581).1

primary endpoint: Percent of patients with ≥1 new vertebral fracture from ACTIVE trial baseline through 6 months of alendronate treatment (Month 25).§§§1

SECONDARY endpoints:

  • Percent of patients with ≥1 new nonvertebral fracture from ACTIVE trial baseline through 6 months of alendronate treatment (Month 25)¶¶¶1,4
  • Mean percentage change in BMD at lumbar spine, total hip, and femoral neck from ACTIVE trial baseline through Month 25¶¶¶1,4

EXPLORATORY ENDPOINTS:

  • Percent of patients with ≥1 new vertebral§§§ and nonvertebral fracture at the end of the ACTIVExtend trial (Month 43) §§§
  • Mean percentage change in BMD at lumbar spine, total hip, and femoral neck from ACTIVE trial baseline through Month 43¶¶¶5

§§§Results reported in the modified ITT population, which included patients who had both pretreatment and posttreatment spine radiographs.1
¶¶¶Results reported in the ITT population, which included patients randomized in the efficacy study. Nonvertebral fractures excluded fractures of the sternum, patella, toes, fingers, skull, and face, and those associated with high trauma.1,4,5

BMD=bone mineral density; ITT=intent-to-treat.

TYMLOS fracture risk reduction was preserved with follow-on therapy.1,4,5

Sustained protection against vertebral fracture was demonstrated for an additional 2 years in the ACTIVExtend trial.###1,4,5

The incidence of new vertebral fractures at 25 months was 0.6% in patients treated with TYMLOS then alendronate, compared to 4.4% in patients treated with placebo then alendronate 15 (p<0.0001). The relative risk reduction in new vertebral fractures at 25 months was 87% for patients treated with TYMLOS then alendronate, compared to patients treated with placebo then alendronate, and the absolute risk reduction was 3.9%. During the full 43-month treatment period, 0.9% of evaluable women in the ABL/ALN group experienced a new radiographic vertebral fracture vs 5.6% of women in the PBO/ALN group, an 84% relative risk reduction (RRR, P < 0.001).Kaplan-Meier incidence rates for other reported fracture types were significantly lower for ABL/ALN vs PBO/ALN (all P<0.05).The incidence of new vertebral fractures at 25 months was 0.6% in patients treated with TYMLOS then alendronate, compared to 4.4% in patients treated with placebo then alendronate 15 (p<0.0001). The relative risk reduction in new vertebral fractures at 25 months was 87% for patients treated with TYMLOS then alendronate, compared to patients treated with placebo then alendronate, and the absolute risk reduction was 3.9%. During the full 43-month treatment period, 0.9% of evaluable women in the ABL/ALN group experienced a new radiographic vertebral fracture vs 5.6% of women in the PBO/ALN group, an 84% relative risk reduction (RRR, P < 0.001).Kaplan-Meier incidence rates for other reported fracture types were significantly lower for ABL/ALN vs PBO/ALN (all P<0.05).

###TYMLOS or placebo for 18 months, followed by 1 month of no treatment, then up to 24 months of open-label alendronate.1
****Results reported in the modified ITT population, which included patients who had both pretreatment and posttreatment spine radiographs.1,5
††††95% CI: 59, 96.1
‡‡‡‡95% CI: 2.1, 5.9. 1
§§§§95% CI: 58, 94.3
¶¶¶¶95% CI: 2.69, 6.99.

BMD gains with TYMLOS were maintained with follow-on therapy.3

Patients significantly increased BMD with TYMLOS and maintained it after transitioning to alendronate antiresorptive therapy.1,4,5

In a 25-month analysis of the secondary endpoint,#### significant increases in BMD achieved with TYMLOS at 18 months were maintained after transitioning to 6 months of follow-on therapy with alendronate (TYMLOS vs placebo; P>0.001 at all sites)1,4:

  • Lumbar spine—12.8% vs 3.5%; treatment difference: 9.3%
  • Total hip—5.5% vs 1.4%; treatment difference: 4.1% new vertebral fracture incidence
  • Femoral neck—4.5% vs 0.5%; treatment difference: 4.1%
Bar graphs showing reduction in new vertebral fracture and nonvertebral fracture between TYMLOS and placebo at 18 monthsBar graphs showing reduction in new vertebral fracture and nonvertebral fracture between TYMLOS and placebo at 18 months

####TYMLOS or placebo for 18 months, followed by 1 month of no treatment, then up to 24 months of open-label alendronate. The primary and secondary efficacy endpoints for the extension study were at 25 months. The 43-month data are exploratory endpoints. Results reported in the ITT population, which included patients enrolled in the extension study; mean percentage change in BMD was the last observation carried forward.1,3-5
*****18 months of TYMLOS or placebo to 24 months of open-label alendronate.1

In the ACTIVExtend trial, the overall incidence of adverse events, including severe and SAEs, during the alendronate treatment period was similar for both study groups and was consistent with the recognized profile of alendronate.1,4,5

ALN=alendronate; ARR=absolute risk reduction; BMD=bone mineral density; CI=confidence interval; ITT=intent-to-treat; SAEs=serious adverse events.

Approved for men with osteoporosis at high risk for fracture.1

TYMLOS rebuilds a foundation of new bone.1

Efficacy was established in men with the ATOM trial.1,7

ATOM evaluated the efficacy and safety of TYMLOS in men.1,7

IN MEN

Study Design: A Phase 3 randomized, double-blind, placebo-controlled study in men with osteoporosis (N=228) aged 42 to 85 years who were randomized to receive TYMLOS 80 mcg (n=149) or placebo (n=79) subcutaneously once daily for 12 months to assess efficacy and safety of abaloparatide injection.1

Primary endpoint: Change in lumbar spine BMD at 12 months compared with placebo.1

SECONDARY endpoints:

  • Percent change from baseline in total hip and femoral neck BMD at 12 months1,7
  • Percent change from baseline in BMD at 3 and 6 months for lumbar spine, total hip, and femoral neck7

TYMLOS quickly and significantly increased BMD in vertebral and nonvertebral bone.1,7

The primary endpoint was the percent change from baseline in lumbar spine BMD at 12 months in patients treated with TYMLOS compared to placebo. Treatment with TYMLOS for 12 months in Study 019 resulted in significant increases in BMD compared to placebo at the lumbar spine, total hip, and femoral neck, each with p<0.0001.The primary endpoint was the percent change from baseline in lumbar spine BMD at 12 months in patients treated with TYMLOS compared to placebo. Treatment with TYMLOS for 12 months in Study 019 resulted in significant increases in BMD compared to placebo at the lumbar spine, total hip, and femoral neck, each with p<0.0001.

†††††99% CI: 5.1, 9.6.11
‡‡‡‡‡99% CI: 1.0, 3.2.1
§§§§§99% CI: 1.4, 4.2.1

Significantly higher BMD gains were observed at 3 and 6 months with TYMLOS compared to placebo.7

Bar graphs showing reduction in new vertebral fracture and nonvertebral fracture between TYMLOS and placebo at 18 monthsBar graphs showing reduction in new vertebral fracture and nonvertebral fracture between TYMLOS and placebo at 18 months

There was no evidence of differences in the effects of TYMLOS on BMD at Month 12 across subgroups defined by age, race, ethnicity, geographic region, presence or absence of prior fracture, and BMD at baseline.

TYMLOS showed a consistent safety profile in the ATOM trial.1

The safety profile for men is consistent with the known safety profile in postmenopausal women with osteoporosis.1

Bar graphs showing reduction in new vertebral fracture and nonvertebral fracture between TYMLOS and placebo at 18 monthsBar graphs showing reduction in new vertebral fracture and nonvertebral fracture between TYMLOS and placebo at 18 months

¶¶¶¶¶Adverse reactions reported in ≥2% of TYMLOS-treated patients.11
#####Hypercalcemia was defined as albumin-correctedserum calcium of at least 10.8 mg/dL (2.67 mmol/L) at any time point.1
BMD=bone mineral density; CI=confidence interval.

Learn About How TYMLOS WorksSee TYMLOS Dosing Information
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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.