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Introduction

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Generic Name(s):

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Abaloparatide, a synthetic human parathyroid hormone (parathormone, PTH)-related peptide analog, is an osteoanabolic agent.1,  2,  5,  6,  7

Uses

Osteoporosis

Postmenopausal Women with Osteoporosis

Abaloparatide is used in the management of osteoporosis in postmenopausal women who are at high risk for fractures (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or those intolerant of or failing to respond to other therapy for osteoporosis.1,  2,  3,  4 The drug has been shown in clinical studies to reduce the risk of vertebral fractures and nonvertebral fractures in these patients.1 Because of a possible risk of osteosarcoma, use of abaloparatide for a cumulative period of more than 2 years during a patient's lifetime is not recommended.1

Efficacy of abaloparatide in the management of postmenopausal osteoporosis was established in an 18-month, double-blind, placebo-controlled clinical study (Abaloparatide-sc Comparator Trial in Vertebral Endpoints [ACTIVE]) in ambulatory postmenopausal women (mean age 69 years [range 49-86 years]; approximately 80% of these patients were Caucasian, 24% Hispanic, 16% Asian, and 3% Black).1,  2,  3,  4 Patients were eligible for study inclusion if they had a bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) T-score of -2.5 and > -5 at the lumbar spine or femoral neck, with radiographic evidence of at least 2 mild vertebral fractures or at least 1 moderate vertebral fracture or with a history of a low-trauma fracture of the forearm, humerus, sacrum, pelvis, hip, femur, or tibia within the past 5 years.4 Women older than 65 years of age who met fracture criteria but had a BMD T-score -2 and > -5 were included.4 Women older than 65 years of age who failed to meet fracture criteria also were eligible for inclusion in the study if either BMD T-score was -3 and > -5.4 In addition, normal serum concentrations for calcium, intact PTH, phosphorus, and alkaline phosphatase, as well as a 25-hydroxyvitamin D concentration exceeding 15 ng/mL, were required for study eligibility.4 Patients who experienced more than 4 mild or moderate or any severe vertebral fractures, had fewer than 2 evaluable lumbar vertebrae by DXA, had hip BMD that was not evaluable, exhibited evidence of metabolic bone disease or malabsorption, received drug therapy that would interfere with bone metabolism, received bisphosphonate therapy for more than 3 months in the past 5 years or denosumab within the past year, or were at an increased risk for or had a history of osteosarcoma were not included in the study.2,  4

Patients were randomized in a 1:1:1 ratio to receive blinded subcutaneous abaloparatide 80 mcg or placebo once daily or open-label teriparatide 20 mcg once daily.1,  2,  3,  4 Patients also received supplemental calcium (500-1000 mg daily) and vitamin D (400-800 units daily).1 The ACTIVE study was followed by an open-label extension period (ACTIVExtend) that included 1139 patients who received abaloparatide or placebo in the original study (92% of those who completed the original study; 558 patients receiving abaloparatide and 581 patients receiving placebo); these patients were no longer receiving abaloparatide or placebo but remained in their original randomized treatment group and received alendronate 70 mg once weekly and concomitant calcium and vitamin D supplements for 6 months.1,  3 The cumulative 25-month efficacy data included 18 months of exposure to abaloparatide or placebo in the original clinical study, 1 month of no therapy, followed by 6 months of alendronate therapy during the extension period.1,  3 The primary efficacy end point was incidence of new vertebral fractures in patients receiving abaloparatide compared with placebo.1 Mean BMD T-scores at baseline were -2.9 at the lumbar spine, -2.1 at the femoral neck, and -1.9 at the total hip; 24% of patients had at least 1 prevalent vertebral fracture while 48% had at least 1 prior nonvertebral fracture.1,  4 Abaloparatide therapy resulted in a substantial reduction in the incidence of new vertebral fractures compared with placebo at 18 months (0.6 versus 4.2%).1,  4 The absolute risk reduction in new vertebral fractures was 3.6% at 18 months and the relative risk reduction was 86% for abaloparatide compared with placebo.1,  3 At 25 months, the incidence of new vertebral fractures was 0.6% in patients receiving abaloparatide followed by alendronate compared with 4.4% in patients receiving placebo followed by alendronate.1 In addition, the absolute risk reduction at 25 months was 3.9% and the relative risk reduction in new vertebral fractures was 87% for patients receiving abaloparatide followed by alendronate therapy compared with patients receiving placebo followed by alendronate therapy.1,  3

Abaloparatide therapy resulted in a substantial reduction in the incidence of nonvertebral fractures after 18 months of therapy plus 1 month of follow-up when no drug was administered (2.7 versus 4.7% in patients receiving abaloparatide compared with those receiving placebo).1,  3 The relative risk reduction in nonvertebral fractures for abaloparatide compared with placebo was 43%, and the absolute risk reduction was 2%.1,  3 Following 6 months of alendronate therapy in the open-label extension period, the cumulative incidence of nonvertebral fractures at 25 months was 2.7% for women originally assigned to receive abaloparatide compared with 5.6% for women originally assigned to receive placebo.1,  3 In addition, the relative risk reduction in nonvertebral fractures was 52% and the absolute risk reduction was 2.9% at 25 months.1,  3 Abaloparatide also demonstrated consistent reductions in the risk of vertebral and nonvertebral fractures regardless of age, years after menopause, presence or absence of prior fracture (vertebral, nonvertebral), and BMD at baseline.1

Abaloparatide therapy for 18 months in the ACTIVE study resulted in substantial increases in BMD compared with placebo at the lumbar spine, total hip, and femoral neck; similar findings were observed in the extension study following 6 months of alendronate therapy.1 Treatment differences in BMD at the lumbar spine, total hip, and femoral neck for abaloparatide versus placebo were 8.8, 3.5, and 3.3%, respectively, at 18 months and 9.3, 4.1, and 4.1%, respectively, at 25 months.1 In addition, abaloparatide demonstrated consistent increases in BMD regardless of age, years after menopause, race, ethnicity, geographic region, presence or absence of prior fracture (vertebral, nonvertebral), and BMD at baseline.1 Bone biopsy specimens were obtained from 71 patients with osteoporosis following 12-18 months of abaloparatide therapy or placebo.1 Qualitative and quantitative histology assessment revealed normal bone architecture and no evidence of woven bone, marrow fibrosis, or mineralization defects.1

Clinical Perspective

In addition to adequate intake of calcium/vitamin D and other lifestyle modifications (e.g., exercise, avoidance of excessive alcohol and tobacco use), experts recommend pharmacologic therapy for osteoporosis in postmenopausal women at high risk of fractures, especially those who have experienced a recent fracture as the benefits of therapy outweigh the risks.106 When selecting an appropriate pharmacologic agent, use of a drug with proven antifracture efficacy is recommended.106 Choice of therapy should be individualized based on the potential benefits (with respect to fracture risk reduction) and adverse effects of therapy as well as patient preferences, comorbidities, drug availability, and costs.106

Clinical practice guidelines generally recommend the use of parathyroid hormone and parathyroid hormone-related protein analogs (e.g., teriparatide, abaloparatide) in postmenopausal women with osteoporosis who are at very high risk of fracture (e.g., those with several or multiple vertebral fractures).106,  107,  109 Treatment duration should be limited to 2 years.106,  107,  109 In such women who have completed a course of teriparatide or abaloparatide, treatment with antiresorptive osteoporosis therapies is recommended to maintain bone density gains.106,  109

Men with Osteoporosis

Abaloparatide is used to increase bone density in men with osteoporosis at high risk of fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or those who have failed or are intolerant to other available osteoporosis therapy.1 Because of a possible risk of osteosarcoma, use of abaloparatide for a cumulative period of more than 2 years during a patient's lifetime is not recommended.1

Efficacy of abaloparatide in the treatment of men with osteoporosis was evaluated in a 12-month, randomized, multicenter, double-blind, placebo-controlled clinical trial (ATOM) in men 40-85 years of age.1,  10 The mean age of patients was 68 years; approximately 95% were Caucasian, 16% were Hispanic, 4% were Asian, and <1% were Black.1 Mean T-scores at baseline were -2.1 at the lumbar spine, -2.1 at the femoral neck, and -1.7 at the total hip.1 Patients also were receiving daily supplemental calcium (500 to 1000 mg) and vitamin D (400 to 800 IU).1 Patients were randomized to receive abaloparatide 80 mcg or placebo by subcutaneous injection once daily for 12 months.1 The primary endpoint was change from baseline in lumbar spine BMD, and key secondary endpoints included BMD change from baseline at the total hip and femoral neck.1,  10 Treatment with abaloparatide for 12 months resulted in significant increases in BMD compared to placebo at the lumbar spine, total hip, and femoral neck.1,  10 Treatment differences in BMD at the lumbar spine, total hip, and femoral neck for abaloparatide versus placebo were 7.3, 2.1, and 2.8%, respectively, at 12 months.1 The treatment effect of abaloparatide was consistent across subgroups defined by age, race, ethnicity, geographic region, presence or absence of prior fracture, and BMD at baseline.1 Because of the small number of fractures in this study, no meaningful comparison could be made between the treatment groups to determine effects on fracture reduction.10

Clinical Perspective

Although osteoporosis is more common in women than in men, men experience greater fracture-related morbidity and mortality.10,  11,  108 In addition to adequate intake of calcium/vitamin D and other lifestyle modifications (e.g., exercise, avoidance of excessive alcohol and tobacco use), experts recommend pharmacologic therapy for osteoporosis in men 50 years of age with high risk of fracture.108 Clinical practice guidelines published by the Endocrine Society recommend that men at high risk of fracture be treated with a drug approved by a regulatory agency for the treatment of osteoporosis in men; unapproved agents should be used only if approved agents cannot be administered.108 Selection of an appropriate therapy should be individualized based on factors such as fracture history, severity of osteoporosis (T-scores), risk of hip fracture, patterns of BMD, comorbid conditions, and cost.108

Dosage and Administration

General

Pretreatment Screening

Patient Monitoring

Other General Considerations

Administration

Abaloparatide is administered by subcutaneous injection once daily.1 Subcutaneous injections should be administered into the periumbilical region of the abdomen (taking care to avoid the 2-inch area around the navel) at the same time every day.1 The injection site should be rotated with each administration.1 The drug should not be given by IV or IM administration.1

Abaloparatide is commercially available as a clear and colorless solution in a single-patient-use prefilled injection pen that delivers 80 mcg of the drug per actuation.1 Prior to injection, abaloparatide should be visually inspected for particulate matter and discoloration.1 The solution should not be used if it contains solid particles or appears cloudy or colored.1 Each injection pen may be used for up to 30 days after the first injection and should then be disposed of properly, even if the injection pen contains unused solution.1

Patients and caregivers should receive appropriate training and instruction on the proper use and disposal of the abaloparatide injection pen.1

Abaloparatide should be administered initially in a setting in which the patient can assume a supine or sitting position if symptoms of orthostatic hypotension occur.1

Dosage

Postmenopausal Women with Osteoporosis

For the treatment of osteoporosis in postmenopausal women who are at high risk for fractures, or patients who have failed or are intolerant to other available osteoporosis therapy, the recommended dosage of abaloparatide is 80 mcg once daily by subcutaneous injection.1 Use of abaloparatide for more than 2 years during a patient's lifetime is not recommended.1

Men with Osteoporosis

For the treatment of osteoporosis in men who are at high risk for fractures, or patients who have failed or are intolerant to other available osteoporosis therapy, the recommended dosage of abaloparatide is 80 mcg once daily by subcutaneous injection.1 Use of abaloparatide for more than 2 years during a patient's lifetime is not recommended.1

Special Populations

Hepatic Impairment

The manufacturer makes no specific dosage recommendations for patients with hepatic impairment.1

Renal Impairment

The manufacturer states that no dosage adjustment of abaloparatide is necessary in patients with mild, moderate, or severe renal impairment.1

Cautions

Contraindications

Warnings/Precautions

Osteosarcoma

Abaloparatide caused a dose-dependent increase in the incidence of osteosarcoma in male and female rats.1 This effect was observed at systemic exposures 4-28 times the exposure in humans at a dose of 80 mcg.1 It is not known whether abaloparatide causes osteosarcoma in humans.1 Osteosarcoma has been reported in patients treated with a parathyroid hormone (PTH) analog during postmarketing experience; however, an increased risk of osteosarcoma has not been observed in observational studies in humans.1 There are limited data assessing the risk of osteosarcoma beyond 2 years of abaloparatide and/or use of a PTH analog.1 Cumulative use of abaloparatide for more than 2 years during a patient's lifetime is not recommended.1

Avoid use of abaloparatide in patients with an increased baseline risk of osteosarcoma (e.g., patients with open epiphyses, metabolic bone diseases other than osteoporosis including Paget's disease of the bone, bone metastases or history of skeletal malignancies, or hereditary disorders predisposing to osteosarcoma).1

Orthostatic Hypotension

Orthostatic hypotension may occur with use of abaloparatide, generally within 4 hours of administration.1 Symptoms may include dizziness, palpitations, tachycardia, or nausea, and may resolve if the patient assumes a reclining position.1 The first several doses of abaloparatide should be administered in a setting in which the patient can sit or recline if necessary until symptoms resolve.1

In women with postmenopausal osteoporosis, an orthostatic decline of 20 mm Hg or more in systolic blood pressure or 10 mm Hg or more in diastolic blood pressure at 1 hour following administration of the first dose occurred in 4 or 3% of patients receiving abaloparatide or placebo, respectively.1 However, the incidence of orthostatic hypotension was generally similar between the treatment groups at later time points.1 Adverse effects of orthostatic hypotension were reported in 1% of patients receiving abaloparatide and 0.5% of patients receiving placebo; dizziness occurred at a higher rate in patients receiving abaloparatide (10%) compared with patients receiving placebo (6%).1

In men with osteoporosis, orthostatic blood pressure declines of 20 mm Hg or more in systolic blood pressure or 10 mm Hg or more in diastolic blood pressure at 1 hour following the first injection occurred in 6% of patients receiving abaloparatide and 3% of those receiving placebo.1 Adverse effects of orthostatic hypotension were reported in 1% of patients receiving abaloparatide and no patients receiving placebo.1 Dizziness was reported by more abaloparatide-treated patients compared to placebo (9% versus 1%).1

Hypercalcemia

Hypercalcemia may occur in patients receiving abaloparatide therapy.1

Hypercalcemia (defined as albumin-corrected serum calcium concentration of 10.7 mg/dL or more at 4 hours following administration of the drug) was reported in 3 or 0.1% of women with postmenopausal osteoporosis receiving abaloparatide or placebo, respectively, in a clinical trial; 0.2% of patients receiving abaloparatide discontinued the study because of this adverse effect compared with no patients receiving placebo.1 Hypercalcemia occurred at a higher rate in patients with compromised renal function (i.e., mild or moderate impairment [4%]) compared with patients with normal renal function (1%).1

In men with osteoporosis, hypercalcemia (defined as albumin-corrected serum calcium of 10.8 mg/dL or more at 4 hours following administration of the drug) occurred in 3% of abaloparatide-treated patients and no patients who received placebo.1 Pre-dose serum calcium was similar to baseline in both groups.1 Hypercalcemia occurred at a higher rate in patients with compromised renal function (i.e., mild or moderate impairment [4%]) compared with those having normal renal function (0%).1

Abaloparatide therapy is not recommended for use in patients with preexisting hypercalcemia or in those with an underlying hypercalcemic disorder (e.g., primary hyperparathyroidism) because of the possibility of exacerbating hypercalcemia.1

Hypercalciuria and Urolithiasis

Abaloparatide therapy may cause hypercalciuria.1 It is not known whether abaloparatide may exacerbate urolithiasis in patients with active urolithiasis or a history of the condition.1

In women with postmenopausal osteoporosis, the overall incidence of urinary calcium-to-creatinine ratio greater than 400 mg/g was higher in patients receiving abaloparatide compared with those receiving placebo (20 versus 15%), and urolithiases were reported in 2.1 or 1.7% of patients receiving abaloparatide or placebo, respectively.1

In men with osteoporosis, the overall incidence of urinary calcium-to-creatinine ratio greater than 400 mg/g was not higher with abaloparatide than with placebo.1 Urolithiases were reported in 2% of abaloparatide-treated patients and 1% of placebo-treated patients.1

Measurement of urinary calcium excretion should be considered if active urolithiasis or preexisting hypercalciuria is suspected.1

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity with abaloparatide.1

In clinical studies in postmenopausal women with osteoporosis, anti-abaloparatide antibodies were detected in 41% of patients; of these patients, 26% developed neutralizing antibodies to the drug.1 Some of these patients developed antibodies with cross-reactivity to parathyroid hormone related peptide (PTHrP), and one patient developed cross-reactive antibodies to PTH.1 No clinically important effects on safety or efficacy of the drug were observed in patients who tested positive for anti-abaloparatide antibodies.1

In clinical studies in men with osteoporosis, anti-abaloparatide antibodies were detected in 25% of patients; of these patients, 1.4% developed neutralizing antibodies to the drug.1 No patients developed cross-reactivity to PTHrP or PTH.1 No clinically important effects on safety or efficacy of the drug were observed in patients who tested positive for anti-abaloparatide antibodies.1

Specific Populations

Pregnancy

Abaloparatide should not be used in females of reproductive potential.1 There are no data regarding use of abaloparatide in pregnant women to inform any drug-associated risks.1 Animal reproduction studies with abaloparatide have not been performed.1

Lactation

It is not known whether abaloparatide is distributed into milk in humans or whether the drug has any effects on milk production or the breast-fed infant.1

Pediatric Use

Safety and efficacy of abaloparatide have not been established in pediatric patients.1 Use of abaloparatide is not recommended in pediatric patients with open epiphyses or hereditary disorders predisposing to osteosarcoma because of an increased baseline risk of osteosarcoma.1

Geriatric Use

Of the total number of patients in the postmenopausal osteoporosis clinical studies of abaloparatide, 82% of patients were 65 years of age, and 19% were 75 years of age.1 In the study in men with osteoporosis, 74% of patients were 65 years of age and 23% were 75 years of age.1 No overall differences in safety or efficacy were observed between geriatric patients and younger adults;1 however, greater sensitivity of some older patients cannot be ruled out.1

Hepatic Impairment

Information is lacking regarding exposure of abaloparatide in patients with hepatic impairment, and no specific dosage recommendations are available for this patient population.1

Renal Impairment

Following subcutaneous administration of abaloparatide (single 80-mcg dose) in individuals with normal or compromised renal function, peak plasma concentrations of the drug were increased by 1.3- or 1.4-fold and AUC was increased by 1.7- or 2.1-fold in individuals with moderate or severe renal impairment, respectively, compared with those having normal renal function.1 In individuals with mild renal impairment, AUC was increased by 1.2-fold but peak plasma concentrations were not increased.1,  9 Because exposure of abaloparatide may be increased in patients with severe renal impairment, such patients receiving abaloparatide should be monitored for potential adverse effects; however, dosage adjustment is not required.1

Common Adverse Effects

Common adverse effects reported with abaloparatide in postmenopausal women at an incidence 2% include hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain, and vertigo.1

Common adverse effects reported with abaloparatide in men with osteoporosis at an incidence 2% include injection site erythema, dizziness, arthralgia, injection site swelling, injection site pain, confusion, nausea, diarrhea, abdominal distension, abdominal pain, and bone pain.1

Drug Interactions

No formal drug interaction studies with abaloparatide have been performed to date.1 Abaloparatide does not inhibit or induce cytochrome P-450 (CYP) isoenzymes at therapeutic concentrations based on in vitro studies.1 Abaloparatide is not a substrate of organic anion transporter (OAT)1, OAT3, organic cation transporter (OCT)2, multidrug and toxin extrusion (MATE)1, or MATE2K.1

Other Information

Description

Abaloparatide is a synthetic human parathyroid hormone (parathormone, PTH)-related peptide analog containing 34 amino acids.1,  5,  6,  7,  8 The drug exhibits agonist activity at the PTH receptor type 1 resulting in the activation of cyclic adenosine-3',5'-monophosphate (cAMP) signaling pathway target cells.1,  7 Abaloparatide exhibited an anabolic effect on bone, as demonstrated by elevations in bone mineral density (BMD) and bone mineral content, that correlated with increases in bone strength at vertebral and/or nonvertebral sites in rats and monkeys.1,  6

The absolute bioavailability of abaloparatide following an 80-mcg subcutaneous dose in healthy women is 36%, and median time to peak plasma concentrations is 0.51 hours.1 The mean half-life of abaloparatide is approximately 1 hour and approximately 70% of the drug is bound to plasma proteins in vitro.1 Metabolism of the drug is thought to be mediated by proteolytic degradation; the peptide fragments are principally excreted in urine.1 Abaloparatide exhibited a dose-response relationship for BMD and bone formation markers when the drug was administered once daily for 24 weeks.1 No age-related differences in abaloparatide pharmacokinetics have been observed in men and postmenopausal women ranging from 18-85 years of age.1

Advice to Patients

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Abaloparatide

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for subcutaneous use

80 mcg per dose (total of 30 doses in each prefilled pen)

Tymlos® (available as prefilled pen)

Radius Health

Copyright

AHFS® Drug Information. © Copyright, 1959-2025, Selected Revisions April 20, 2023. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.

References

1. Radius Health, Inc. Tymlos® (abaloparatide) subcutaneous injection prescribing information. Boston, MA; 2022 Dec.

2. Moreira CA, Fitzpatrick LA, Wang Y et al. Effects of abaloparatide-SC (BA058) on bone histology and histomorphometry: The ACTIVE phase 3 trial. Bone . 2017; 97:314-319. [PubMed 27826127]

3. Cosman F, Miller PD, Williams GC et al. Eighteen Months of Treatment With Subcutaneous Abaloparatide Followed by 6 Months of Treatment With Alendronate in Postmenopausal Women With Osteoporosis: Results of the ACTIVExtend Trial. Mayo Clin Proc . 2017; 92:200-210. [PubMed 28160873]

4. 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; 316:722-33. [PubMed 27533157]

5. McCloskey EV, Johansson H, Oden A et al. The Effect of Abaloparatide-SC on Fracture Risk Is Independent of Baseline FRAX Fracture Probability: A Post Hoc Analysis of the ACTIVE Study. J Bone Miner Res . 2017; [PubMed 28474780]

6. Leder BZ, O'Dea LS, Zanchetta JR et al. Effects of abaloparatide, a human parathyroid hormone-related peptide analog, on bone mineral density in postmenopausal women with osteoporosis. J Clin Endocrinol Metab . 2015; 100:697-706. [PubMed 25393645]

7. Cosman F, Hattersley G, Hu MY et al. Effects of Abaloparatide-SC on Fractures and Bone Mineral Density in Subgroups of Postmenopausal Women With Osteoporosis and Varying Baseline Risk Factors. J Bone Miner Res . 2017; 32:17-23. [PubMed 27612281]

8. Hattersley G, Dean T, Corbin BA et al. Binding Selectivity of Abaloparatide for PTH-Type-1-Receptor Conformations and Effects on Downstream Signaling. Endocrinology . 2016; 157:141-9. [PubMed 26562265]

9. Food and Drug Administration. Center for Drug Evaluation and Research. Application number 208743Orig1s000: Clinical pharmacology and biopharmaceutics review(s). From FDA website. [Web]

10. Czerwinski E, Cardona J, Plebanski R et al. The Efficacy and Safety of Abaloparatide-SC in Men With Osteoporosis: A Randomized Clinical Trial. J Bone Miner Res. 2022 Dec;37(12):2435-2442. Epub 2022 Oct 18. [PubMed 36190391]

11. US Preventive Services Task Force; Curry SJ, Krist AH, Owens DK et al. Screening for Osteoporosis to Prevent Fractures: US Preventive Services Task Force Recommendation Statement. JAMA. 2018 Jun 26;319(24):2521-2531. [PubMed 29946735]

106. Eastell R, Rosen CJ, Black DM et al. Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2019 May 1;104(5):1595-1622. [PubMed 30907953]

107. Shoback D, Rosen CJ, Black DM et al. Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Guideline Update. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgaa048. [PubMed 32068863]

108. Watts NB, Adler RA, Bilezikian JP, et al. Osteoporosis in men: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2012 Jun;97(6):1802-22. [PubMed 22675062]

109. 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 May;26(Suppl 1):1-46. [PubMed 32427503]