abaloparatide profile

abaloparatide: synthetic analog of human PTHrP (Parathyroid Hormone-Related Protein) [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

ID Source	ID
PubMed CID	145705876
MeSH ID	M000604476

Synonym
abaloparatide
247062-33-5
abaloparatide acetate

Excerpt	Reference	Relevance
" However, some concerns have been raised due to a somewhat higher occurrence of adverse effects (particularly with palpitations and increased heart rate) or the resultant discontinuation due to these adverse effects when compared to teriparatide."	( Efficacy and safety of abaloparatide for the treatment of post-menopausal osteoporosis. Chiodini, I; Falchetti, A; Gennari, L; Merlotti, D, 2019)	0.51
"Review of heart rate (HR), blood pressure (BP), and cardiovascular-related adverse events (AEs), including major adverse cardiovascular events (MACEs) and heart failure (HF) from: (a) ACTIVE (NCT01343004), a phase 3 trial that randomized 2463 postmenopausal women with osteoporosis to abaloparatide, teriparatide, or placebo for 18 months; (b) ACTIVExtend (NCT01657162), where participants from the abaloparatide and placebo arms received alendronate for 2 years; and (c) a pharmacology study in 55 healthy adults."	( Cardiovascular Safety of Abaloparatide in Postmenopausal Women With Osteoporosis: Analysis From the ACTIVE Phase 3 Trial. Cosman, F; Cummings, SR; Mitlak, B; Peterson, LR; Towler, DA; Wang, Y, 2020)	0.56
" In 1:1 propensity score matched cohorts, time to first NVF following index date, major adverse cardiovascular events (MACE), and MACE + heart failure (HF) were compared between cohorts using a Cox proportional hazards model."	( Comparative effectiveness and cardiovascular safety of abaloparatide and teriparatide in postmenopausal women new to anabolic therapy: A US administrative claims database study. Cooper, C; Cosman, F; Mitlak, B; Varughese, S; Wang, Y; Williams, SA, 2022)	0.72
" The most common (≥5%) treatment-emergent adverse events were injection site reaction, dizziness, nasopharyngitis, arthralgia, bronchitis, hypertension, and headache."	( The Efficacy and Safety of Abaloparatide-SC in Men With Osteoporosis: A Randomized Clinical Trial. Adachi, J; Binkley, N; Cardona, J; Chen, Y; Czerwinski, E; Kendler, D; Knychas, D; Lewiecki, EM; Li, YH; Mitlak, B; Orwoll, E; Pearman, L; Plebanski, R; Recknor, C; Saag, KG; Vokes, T, 2022)	0.72
" Administration site reactions were the most frequently reported adverse events (abaloparatide-sMTS, 94."	( Efficacy and Safety of Transdermal Abaloparatide in Postmenopausal Women with Osteoporosis: A Randomized Study. Annett, M; Binkley, N; Cardona, J; Czerwinski, E; Lawrence, M; Lewiecki, EM; Mitlak, B; Nattrass, SM; Pearman, L; Recknor, C; Silverman, S; Strzelecka, A; Valenzuela, G, 2023)	0.91
"14%) ABL-related adverse events (AEs) through data mining of Food and Drug Administration Adverse Event Reporting System (FAERS) retrospectively."	( A real-world pharmacovigilance study of abaloparatide based on the FDA Adverse Event Reporting System (FAERS). Cheng, Q; Shi, X; Sun, MH; Zhao, YZ; Zou, SP, 2023)	0.91

Excerpt	Relevance	Reference
" A dose-response was observed at 24 weeks across the three doses of abaloparatide-SC and placebo (p = 0."	( Abaloparatide-SC improves trabecular microarchitecture as assessed by trabecular bone score (TBS): a 24-week randomized clinical trial. Banks, K; Bilezikian, JP; Fitzpatrick, LA; Hans, D; Harris, AG; Hattersley, G; Leder, BZ; Shevroja, E; Zanchetta, JR, 2018)	0.48

Timeframe	Studies, This Drug (%)	All Drugs %
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	67 (60.36)	24.3611
2020's	44 (39.64)	2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Publication Type	This drug (%)	All Drugs (%)
Trials	27 (23.28%)	5.53%
Reviews	30 (25.86%)	6.00%
Case Studies	0 (0.00%)	4.05%
Observational	0 (0.00%)	0.25%
Other	59 (50.86%)	84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (18)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
An Open-Label, Randomized, 4-Period Crossover Study Evaluating the Bioequivalence of Two Abaloparatide-sMTS Treatments and the Effect of Small Variations in Wear-Time in Healthy Women. [NCT04936984]	Phase 1	36 participants (Actual)	Interventional	2020-11-16	Completed
Effect of Abaloparatide on Lumbar Disc Degeneration [NCT03708926]	Phase 2	0 participants (Actual)	Interventional	2021-03-31	Withdrawn(stopped due to Inability to obtain drugs from supplier.)
An Open-Label, Single-Arm, Multicenter Study to Evaluate the Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption [NCT03710889]	Phase 3	23 participants (Actual)	Interventional	2018-09-20	Completed
A Prospective, Single Arm Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Usability of Abaloparatide-sMTS in Postmenopausal Women With Low Bone Mineral Density [NCT04366726]	Phase 1	22 participants (Actual)	Interventional	2019-04-09	Completed
An Open-Label Phase 2 Study of Abaloparatide to Mitigate Distal Femoral Bone Loss Following Total Knee Arthroplasty [NCT04167163]	Phase 4	58 participants (Actual)	Interventional	2020-01-10	Active, not recruiting
Effect of PTH Analog on Union Rates of Type II Odontoid Fractures in Older Adults [NCT04760782]	Phase 2	20 participants (Anticipated)	Interventional	2022-05-18	Recruiting
A Phase I Pilot Study of Abaloparatide + Bevacizumab in Myelodysplastic Syndromes [NCT03746041]	Phase 1	20 participants (Actual)	Interventional	2019-02-14	Completed
An Open-Label, Randomized, 2-Cohort, 2-Period Crossover Pharmacokinetic Study of Abaloparatide-SC and Abaloparatide-sMTS in Healthy Men and Women [NCT04663464]	Phase 1	52 participants (Actual)	Interventional	2020-11-16	Completed
A Randomized, Parallel-Group, Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis [NCT00542425]	Phase 2	222 participants (Actual)	Interventional	2007-04-30	Completed
A Randomized, Double-blind, Placebo-controlled, Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of Abaloparatide-SC for the Treatment of Men With Osteoporosis [NCT03512262]	Phase 3	228 participants (Actual)	Interventional	2018-05-03	Completed
Phase II Trial of Abaloparatide vs. Placebo in Post-Menopausal Women Receiving Initial Spinal Fusion Surgery [NCT03841058]	Phase 2	72 participants (Anticipated)	Interventional	2019-08-14	Recruiting
A Randomized, Double-blind, Placebo-Controlled, Comparative Multicenter Phase 3 Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Injection for Prevention of Fracture in Ambulatory Postmenopausal Women With Severe Osteoporosis and at [NCT01343004]	Phase 3	2,463 participants (Actual)	Interventional	2011-04-30	Completed
Time to Healing, Loss of Fixation, and Loss of Alignment in Supracondylar Distal Femur Fractures Among a Geriatric Population Treated With Abaloparatide: A Double-Blind Placebo Controlled Study [NCT04626141]	Phase 4	76 participants (Anticipated)	Interventional	2023-09-30	Not yet recruiting
Abaloparatide Versus Placebo for Pelvic Fracture Healing - A Phase 2 Randomized Controlled Trial [NCT04249232]	Phase 2	78 participants (Anticipated)	Interventional	2020-09-17	Recruiting
A Retrospective, Observational Cohort Study Evaluating the Effectiveness and Cardiovascular Safety of Abaloparatide in Postmenopausal Women New to Anabolic Therapies [NCT04974723]		16,000 participants (Anticipated)	Observational	2021-07-01	Active, not recruiting
A Randomized, Non-inferiority, Phase 3, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Abaloparatide-sMTS for the Treatment of Postmenopausal Women With Osteoporosis (the wearABLe Study) [NCT04064411]	Phase 3	511 participants (Actual)	Interventional	2019-08-05	Completed
Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone [NCT04467983]	Phase 4	70 participants (Anticipated)	Interventional	2021-02-01	Recruiting
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of BA058 Administered Via a Coated Transdermal Microarray Delivery System (BA058 Transdermal) in Healthy Postmenopausal Women With Osteoporosis [NCT01674621]	Phase 2	250 participants (Actual)	Interventional	2012-09-25	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Trial	Outcome
NCT00542425 (5) [back to overview]	Change in Bone Mineral Density, Total Spine.
NCT00542425 (5) [back to overview]	Change in Bone Mineral Density, Femoral Neck.
NCT00542425 (5) [back to overview]	Change in Bone Mineral Density, Total Hip.
NCT00542425 (5) [back to overview]	Change in Bone Mineral Density, Total Spine.
NCT00542425 (5) [back to overview]	Change in Marker of Bone Metabolism, PINP
NCT01343004 (6) [back to overview]	Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18
NCT01343004 (6) [back to overview]	Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months
NCT01343004 (6) [back to overview]	Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months
NCT01343004 (6) [back to overview]	Number of Participants With Non-vertebral Fractures at 18 Months
NCT01343004 (6) [back to overview]	Number of Participants With New Vertebral Fractures at 18 Months
NCT01343004 (6) [back to overview]	Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18
NCT01674621 (14) [back to overview]	Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4
NCT01674621 (14) [back to overview]	Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4
NCT01674621 (14) [back to overview]	Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4
NCT01674621 (14) [back to overview]	Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result
NCT01674621 (14) [back to overview]	Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months
NCT01674621 (14) [back to overview]	Percent Change From Baseline in BMD of Forearm at 6 Months
NCT01674621 (14) [back to overview]	Percent Change From Baseline in BMD of Total Hip at 6 Months
NCT01674621 (14) [back to overview]	Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months
NCT01674621 (14) [back to overview]	Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months
NCT01674621 (14) [back to overview]	Percent Change From Baseline in Serum Osteocalcin at 6 Months
NCT01674621 (14) [back to overview]	Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months
NCT01674621 (14) [back to overview]	Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months
NCT01674621 (14) [back to overview]	Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
NCT01674621 (14) [back to overview]	Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes
NCT03512262 (13) [back to overview]	Percent Change From Baseline in Lumbar Spine BMD at Month 12
NCT03512262 (13) [back to overview]	Percent of Participants Experiencing BMD Gains From Baseline of > 0%, > 3%, and > 6% at the Lumbar Spine, Femoral Neck, and Total Hip
NCT03512262 (13) [back to overview]	Percent of Participants With Change in Disease Status
NCT03512262 (13) [back to overview]	Percent Change in Total Hip BMD From Baseline at Month 6
NCT03512262 (13) [back to overview]	Number of Participants With New Clinical Fractures
NCT03512262 (13) [back to overview]	Percent Change From Baseline in Distal One-third Radius BMD at Month 12
NCT03512262 (13) [back to overview]	Percent Change From Baseline in Femoral Neck BMD at Month 12
NCT03512262 (13) [back to overview]	Percent Change From Baseline in Femoral Neck BMD at Month 6
NCT03512262 (13) [back to overview]	Percent Change From Baseline in Lumbar Spine BMD at Month 6
NCT03512262 (13) [back to overview]	Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) at Month 12
NCT03512262 (13) [back to overview]	Percent Change From Baseline in Serum Procollagen Type I N-terminal Propeptide (s-PINP) at Month 12
NCT03512262 (13) [back to overview]	Percent Change From Baseline in Total Hip BMD at Month 12
NCT03512262 (13) [back to overview]	Percent Change From Baseline in Ultra-Distal Radius BMD at Month 12
NCT03710889 (4) [back to overview]	Change in Serum Procollagen Type I N-terminal Propeptide (s-P1NP) From Baseline at Month 1 and Month 3
NCT03710889 (4) [back to overview]	Change in Serum Carboxy-Terminal Cross-Linking Telopeptide of Type I Collagen (s-CTX) From Baseline at Month 1 and Month 3
NCT03710889 (4) [back to overview]	Change From Baseline in Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Envelope at Month 3
NCT03710889 (4) [back to overview]	Change From Baseline in Bone Formation Rate/Bone Surface (BFR/BS) in the Cancellous Envelope at Month 3
NCT04064411 (3) [back to overview]	Percent Change From Baseline in Femoral Neck BMD at Month 12
NCT04064411 (3) [back to overview]	Percent Change From Baseline in Lumbar Spine BMD at Month 12
NCT04064411 (3) [back to overview]	Percent Change From Baseline in Total Hip BMD at Month 12
NCT04366726 (6) [back to overview]	Change From Baseline of Serum Phosphorus to Predose and Postdose on Day 29
NCT04366726 (6) [back to overview]	Change From Baseline of Serum Calcium (Albumin-Corrected) to Predose and Postdose on Day 29
NCT04366726 (6) [back to overview]	Percent Change From Baseline of Serum Procollagen Type I N-Terminal Propeptides (s-PINP) at Day 29
NCT04366726 (6) [back to overview]	Change From Baseline of Cyclic Adenosine Monophosphate (cAMP) to Day 29
NCT04366726 (6) [back to overview]	Abaloparatide Maximum Plasma Concentration (Cmax) on Day 29
NCT04366726 (6) [back to overview]	Abaloparatide Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) on Day 29

Change in Bone Mineral Density, Total Spine.

Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 24. (NCT00542425)
Timeframe: 6 months

Intervention	Percent change from baseline (Mean)
Placebo	1.22
BA058 20 µg	3.30
BA058 40 µg	5.21
BA058 80 µg	6.11
Teriparatide	5.47

[back to top]

Change in Bone Mineral Density, Femoral Neck.

Femoral neck bone mineral density (BMD) was analyzed by DXA at Week 24. (NCT00542425)
Timeframe: 6 months

Intervention	Percent change from baseline (Mean)
Placebo	0.79
BA058 20 µg	2.69
BA058 40 µg	2.20
BA058 80 µg	3.07
Teriparatide	1.07

[back to top]

Change in Bone Mineral Density, Total Hip.

Total analyzable hip bone mineral density (BMD) was analyzed by DXA at Week 24. (NCT00542425)
Timeframe: 6 months

Intervention	Percent change from baseline (Mean)
Placebo	0.39
BA058 20 µg	1.43
BA058 40 µg	1.97
BA058 80 µg	2.60
Teriparatide	0.45

[back to top]

Change in Bone Mineral Density, Total Spine.

Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 48. (NCT00542425)
Timeframe: 12 months

Intervention	Percent change from baseline (Mean)
Placebo	0.74
BA058 20 µg	5.14
BA058 40 µg	9.84
BA058 80 µg	12.94
Teriparatide	8.63

[back to top]

Change in Marker of Bone Metabolism, PINP

PINP, N-terminal propeptide of type I procollagen, is a marker of anabolic bone growth. (NCT00542425)
Timeframe: 6 months

Intervention	Percent change from baseline (Mean)
Placebo	-13.1
BA058 20 µg	20.0
BA058 40 µg	90.8
BA058 80 µg	97.2
Teriparatide	154.3

[back to top]

Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18

(NCT01343004)
Timeframe: Baseline and 18 months

Intervention	percent change (Mean)
Placebo	-0.08
BA058 80 mcg (Abaloparatide)	3.44
Teriparatide	2.81

[back to top]

Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months

(NCT01343004)
Timeframe: Basline and 18 months

Intervention	percent change from baseline (Mean)
Placebo	0.48
BA058 80 mcg (Abaloparatide)	9.20
Teriparatide	9.12

[back to top]

Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months

(NCT01343004)
Timeframe: 18 months

Intervention	Hypercalcemic events (Number)
Placebo	5
BA058 80 mcg (Abaloparatide)	15
Teriparatide	34

[back to top]

Number of Participants With Non-vertebral Fractures at 18 Months

(NCT01343004)
Timeframe: 18 months

Intervention	Participants (Number)
Placebo	33
BA058 80 mcg (Abaloparatide)	18
Teriparatide	24

[back to top]

Number of Participants With New Vertebral Fractures at 18 Months

(NCT01343004)
Timeframe: 18 months

Intervention	participants (Number)
Placebo	30
BA058 80 mcg (Abaloparatide)	4
Teriparatide	6

[back to top]

Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18

(NCT01343004)
Timeframe: Baseline and 18 months

Intervention	percent change (Mean)
Placebo	-0.44
BA058 80 mcg (Abaloparatide)	2.90
Teriparatide	2.26

[back to top]

Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4

Hematology laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: white blood cell (Grade 3: 1.0-1.9*10^9/liter [L]; Grade 4 <1.0*10^9/L), platelets (Grade 3: 25.0-49.9*10^9/L; Grade 4: <25.0*10^9/L), haemoglobin (Grade 3: 65.0-79.0 grams [g]/L or 4.0-4.9 mmol/L; Grade 4: <65.0 g/L or <4.0 millimole [mmol]/L), granulocytes/bands (Grade 3: 0.5-0.9*10^9/L; Grade 4: <0.5*10^9/L), lymphocytes (Grade 3: 0.5-0.9*10^9/L; Grade 4: <0.5 *10^9/L), haemorrhage (Grade 3: gross, 3 - 4 units transfusion per episode; Grade 4: massive, > 4 units transfusion per episode). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. (NCT01674621)
Timeframe: Baseline up to 6 Months

Intervention	Participants (Count of Participants)
Abaloparatide Transdermal (50 mcg)	6
Abaloparatide Transdermal (100 mcg)	5
Abaloparatide Transdermal (150 mcg)	4
Abaloparatide Injection (80 mcg)	1
Abaloparatide Transdermal Placebo (0 mcg)	5

[back to top]

Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4

Coagulation laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: prothrombin time (quick) (Grade 3: 1.51%-2.00%*normal, Grade 4: >2.00%*normal), partial thromboplastin time (Grade 3: 2.34-3.00 seconds [sec], Grade 4: >3.00 secs*normal). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. (NCT01674621)
Timeframe: Baseline up to 6 Months

Intervention	Participants (Count of Participants)
Abaloparatide Transdermal (50 mcg)	0
Abaloparatide Transdermal (100 mcg)	0
Abaloparatide Transdermal (150 mcg)	0
Abaloparatide Injection (80 mcg)	0
Abaloparatide Transdermal Placebo (0 mcg)	0

[back to top]

Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4

Chemistry laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: sodium, potassium, chloride, inorganic phosphorus, albumin, total protein (Grade 3: 4 (+), >1.0 g%, or >10 g/L; Grade 4: nephrotic syndrome), glucose, blood urea nitrogen (BUN), creatinine (Grade 3: 3.1-6.0*normal; Grade 4: >6.0*normal), uric acid, aspartate aminotransferase (AST) (Grade 3: 5.1-20.0 units [U]/L*normal, Grade 4: >20.0 U/L*normal), alanine aminotransferase (ALT) (Grade 3: 5.1-20.0 U/L*normal; Grade 4: >20.0 U/L*normal), gamma-glutamyltranspeptidase (GGT), creatine phosphokinase (CPK), alkaline phosphatase (Grade 3: 5.1-20.0 U/L*normal; Grade 4: >20.0 U/L*normal), total bilirubin (Grade 3: 1.5-3.0*normal; Grade 4: >3.0*normal), lactate dehydrogenase (LDH), cholesterol, triglycerides, total calcium. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. (NCT01674621)
Timeframe: Baseline up to 6 Months

Intervention	Participants (Count of Participants)
Abaloparatide Transdermal (50 mcg)	1
Abaloparatide Transdermal (100 mcg)	0
Abaloparatide Transdermal (150 mcg)	0
Abaloparatide Injection (80 mcg)	0
Abaloparatide Transdermal Placebo (0 mcg)	0

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Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result

The following ECG parameters were recorded: rhythm, heart rate, PR interval, QRS duration and QT/QTc. ECG results that were considered clinically meaningful were to be determined by the Investigator. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. (NCT01674621)
Timeframe: Baseline up to 7 Months

Intervention	Participants (Count of Participants)
Abaloparatide Transdermal (50 mcg)	0
Abaloparatide Transdermal (100 mcg)	0
Abaloparatide Transdermal (150 mcg)	1
Abaloparatide Injection (80 mcg)	2
Abaloparatide Transdermal Placebo (0 mcg)	0

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Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months

(NCT01674621)
Timeframe: Baseline, 6 Months

Intervention	Percent change (Mean)
Abaloparatide Transdermal (50 mcg)	-4.84
Abaloparatide Transdermal (100 mcg)	5.22
Abaloparatide Transdermal (150 mcg)	-5.52
Abaloparatide Injection (80 mcg)	17.30
Abaloparatide Transdermal Placebo (0 mcg)	10.23

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Percent Change From Baseline in BMD of Forearm at 6 Months

Percent change in BMD as specified by DXA scans of the forearm. (NCT01674621)
Timeframe: Baseline, 6 Months

Intervention	Percent change (Mean)
Abaloparatide Transdermal (50 mcg)	-0.24
Abaloparatide Transdermal (100 mcg)	-0.16
Abaloparatide Transdermal (150 mcg)	0.84
Abaloparatide Injection (80 mcg)	0.33
Abaloparatide Transdermal Placebo (0 mcg)	0.05

[back to top]

Percent Change From Baseline in BMD of Total Hip at 6 Months

Percent change in BMD as specified by DXA scans of the total hip. (NCT01674621)
Timeframe: Baseline, 6 Months

Intervention	Percent change (Mean)
Abaloparatide Transdermal (50 mcg)	0.97
Abaloparatide Transdermal (100 mcg)	1.32
Abaloparatide Transdermal (150 mcg)	1.49
Abaloparatide Injection (80 mcg)	2.74
Abaloparatide Transdermal Placebo (0 mcg)	-0.02

[back to top]

Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months

Percent change in BMD as specified by dual energy x-ray absorptiometry (DXA) scans of the lumbar spine. (NCT01674621)
Timeframe: Baseline, 6 Months

Intervention	Percent change (Mean)
Abaloparatide Transdermal (50 mcg)	1.87
Abaloparatide Transdermal (100 mcg)	2.33
Abaloparatide Transdermal (150 mcg)	2.95
Abaloparatide Injection (80 mcg)	5.80
Abaloparatide Transdermal Placebo (0 mcg)	0.04

[back to top]

Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months

(NCT01674621)
Timeframe: Baseline, 6 Months

Intervention	Percent change (Mean)
Abaloparatide Transdermal (50 mcg)	-2.61
Abaloparatide Transdermal (100 mcg)	1.65
Abaloparatide Transdermal (150 mcg)	-8.22
Abaloparatide Injection (80 mcg)	41.11
Abaloparatide Transdermal Placebo (0 mcg)	9.42

[back to top]

Percent Change From Baseline in Serum Osteocalcin at 6 Months

(NCT01674621)
Timeframe: Baseline, 6 Months

Intervention	Percent change (Mean)
Abaloparatide Transdermal (50 mcg)	-4.37
Abaloparatide Transdermal (100 mcg)	6.67
Abaloparatide Transdermal (150 mcg)	-3.83
Abaloparatide Injection (80 mcg)	69.54
Abaloparatide Transdermal Placebo (0 mcg)	-4.21

[back to top]

Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months

(NCT01674621)
Timeframe: Baseline, 6 Months

Intervention	Percent change (Mean)
Abaloparatide Transdermal (50 mcg)	-17.26
Abaloparatide Transdermal (100 mcg)	-8.42
Abaloparatide Transdermal (150 mcg)	-16.63
Abaloparatide Injection (80 mcg)	10.28
Abaloparatide Transdermal Placebo (0 mcg)	-6.76

[back to top]

Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months

(NCT01674621)
Timeframe: Baseline, 6 Months

Intervention	Percent change (Mean)
Abaloparatide Transdermal (50 mcg)	-12.76
Abaloparatide Transdermal (100 mcg)	1.52
Abaloparatide Transdermal (150 mcg)	-6.78
Abaloparatide Injection (80 mcg)	97.64
Abaloparatide Transdermal Placebo (0 mcg)	-7.26

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Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)

A full physical examination included, at a minimum: general appearance, skin, head/ears/eyes/nose/throat, lungs/chest, breasts, heart, abdomen, lymph nodes, musculoskeletal, extremities, and neurologic. Physical examination results that were considered abnormal were determined by the Investigator. A summary of other non-serious adverse events (AEs) and all serious AEs (SAEs), regardless of causality is located in Reported AE section. (NCT01674621)
Timeframe: Baseline up to 6 Months

,,,,

Intervention	Participants (Count of Participants)
	General appearance at Screening	General appearance at 6 months	Skin at Screening	Skin at 6 months	Head at Screening	Head at 6 months	Lungs at Screening	Lungs at 6 months	Breasts at Screening	Breasts at 6 months	Abdomen at Screening	Abdomen at 6 months	Lymph nodes at Screening	Lymph nodes at 6 months	Columna at Screening	Columna at 6 months	Extremities at Screening	Extremities at 6 months	Neurologic at Screening	Neurologic at 6 months
Abaloparatide Injection (80 mcg)	1	1	14	14	5	4	1	1	3	4	9	9	0	0	4	3	23	25	2	3
Abaloparatide Transdermal (100 mcg)	0	0	24	26	3	4	0	0	7	7	8	7	0	0	3	2	13	10	0	0
Abaloparatide Transdermal (150 mcg)	0	1	17	16	2	3	0	0	3	3	4	3	1	0	7	7	14	14	0	0
Abaloparatide Transdermal (50 mcg)	0	0	28	29	6	6	0	0	4	4	7	6	0	0	1	1	21	23	0	0
Abaloparatide Transdermal Placebo (0 mcg)	0	0	21	17	1	2	1	0	11	10	4	3	0	1	1	1	21	21	1	1

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Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes

Vital sign parameters included respiration rate (breaths/minute), body temperature (°C), systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHg), and heart rate (bpm). Number of participants for each TEAE is presented. The same participant may be included in more than one TEAE category. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. (NCT01674621)
Timeframe: Baseline up to 7 Months

,,,,

Intervention	Participants (Count of Participants)
	Hypertension	Blood Pressure Increased	Heart Rate increased	Dyspnoea	Dizziness
Abaloparatide Injection (80 mcg)	0	1	0	1	1
Abaloparatide Transdermal (100 mcg)	1	0	0	0	0
Abaloparatide Transdermal (150 mcg)	0	1	1	0	0
Abaloparatide Transdermal (50 mcg)	0	0	0	0	0
Abaloparatide Transdermal Placebo (0 mcg)	0	0	0	0	0

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Percent Change From Baseline in Lumbar Spine BMD at Month 12

Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory. Lumbar spine scans included L1 through L4. Positive changes from baseline indicate improvement in bone health. (NCT03512262)
Timeframe: Baseline, Month 12

Intervention	percent change (Least Squares Mean)
Abaloparatide	8.4820
Placebo	1.1654

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Percent of Participants Experiencing BMD Gains From Baseline of > 0%, > 3%, and > 6% at the Lumbar Spine, Femoral Neck, and Total Hip

Lumbar spine, femoral neck, and total hip BMD were assessed by DXA scans evaluated by a central imaging laboratory. (NCT03512262)
Timeframe: Month 12

Intervention	percentage of participants (Number)
	BMD Increase >0% at All Three Sites	BMD Increase >3% at All Three Sites	BMD Increase >6% at All Three Sites
Abaloparatide	67.2	31.9	9.2
Placebo	15.2	1.5	0.0

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Percent of Participants With Change in Disease Status

"The percentage of participants converting from the categories of osteoporosis to osteopenia or from osteopenia to normal at End of Treatment (Month 12) was assessed. Osteoporosis was defined as lumbar spine or total hip BMD T-score ≤ -2.5. Osteopenia was defined as one of the following:~Lumbar spine > -2.5 and total hip BMD T-score > -2.5 and < -1.0~Lumbar spine > -2.5 and < -1.0 and total hip BMD T-score > -2.5~Normal was defined as lumbar spine and total hip BMD T-score ≥ -1.0." (NCT03512262)
Timeframe: Baseline through Month 12

Intervention	percentage of participants (Number)
	Osteopenia to Normal	Osteopenia to Osteoporosis	Osteoporosis to Normal	Osteoporosis to Osteopenia	Normal to Osteopenia or Osteoporosis
Abaloparatide	8.8	0	2.9	57.1	0
Placebo	8.0	12.0	0	12.8	0

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Percent Change in Total Hip BMD From Baseline at Month 6

Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health. (NCT03512262)
Timeframe: Baseline, Month 6

Intervention	percent change (Least Squares Mean)
Abaloparatide	1.3888
Placebo	0.0267

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Number of Participants With New Clinical Fractures

Radiological evaluations were performed to identify any new clinical fractures (occurring after the screening visit). (NCT03512262)
Timeframe: Baseline through Month 12

Intervention	Participants (Count of Participants)
Abaloparatide	1
Placebo	3

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Percent Change From Baseline in Distal One-third Radius BMD at Month 12

Distal one-third radius BMD was assessed by DXA scans. Positive changes from baseline indicate improvement in bone health. (NCT03512262)
Timeframe: Baseline, Month 12

Intervention	percent change (Least Squares Mean)
Abaloparatide	-0.0138
Placebo	0.7066

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Percent Change From Baseline in Femoral Neck BMD at Month 12

Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health. (NCT03512262)
Timeframe: Baseline, Month 12

Intervention	percent change (Least Squares Mean)
Abaloparatide	2.9766
Placebo	0.1545

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Percent Change From Baseline in Femoral Neck BMD at Month 6

Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health. (NCT03512262)
Timeframe: Baseline, Month 6

Intervention	percent change (Least Squares Mean)
Abaloparatide	1.4790
Placebo	-0.1884

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Percent Change From Baseline in Lumbar Spine BMD at Month 6

Intervention	percent change (Least Squares Mean)
Abaloparatide	5.5436
Placebo	0.6418

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Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) at Month 12

Blood samples were taken to measure s-CTX. Elevated levels of s-CTX indicate increased bone resorption (bone loss). (NCT03512262)
Timeframe: Baseline, Month 12

Intervention	percent change (Mean)
Abaloparatide	89.639
Placebo	15.359

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Percent Change From Baseline in Serum Procollagen Type I N-terminal Propeptide (s-PINP) at Month 12

Blood samples were taken to measure s-PINP, a bone formation marker. s-PINP concentrations reflect the rate of skeletal new bone formation. Increases in s-PINP indicate anabolic biologic response in the bone. (NCT03512262)
Timeframe: Baseline, Month 12

Intervention	percent change (Mean)
Abaloparatide	225.919
Placebo	0.291

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Percent Change From Baseline in Total Hip BMD at Month 12

Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health. (NCT03512262)
Timeframe: Baseline, Month 12

Intervention	percent change (Least Squares Mean)
Abaloparatide	2.1351
Placebo	0.0143

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Percent Change From Baseline in Ultra-Distal Radius BMD at Month 12

Ultra-distal radius BMD was assessed by DXA scans. Positive changes from baseline indicate improvement in bone health. (NCT03512262)
Timeframe: Baseline, Month 12

Intervention	percent change (Least Squares Mean)
Abaloparatide	1.4358
Placebo	-0.1915

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Change in Serum Procollagen Type I N-terminal Propeptide (s-P1NP) From Baseline at Month 1 and Month 3

Blood samples were taken to measure efficacy related markers of bone metabolism at Day 1, Month 1, and Month 3. (NCT03710889)
Timeframe: Baseline (Day 1), Months 1 and 3

Intervention	nanograms (ng)/milliliter (mL) (Median)
	Baseline	Change at Month 1	Change at Month 3
Abaloparatide	54.990	119.155	141.130

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Change in Serum Carboxy-Terminal Cross-Linking Telopeptide of Type I Collagen (s-CTX) From Baseline at Month 1 and Month 3

Blood samples were taken to measure efficacy-related markers of bone metabolism at Day 1, Month 1, and Month 3. (NCT03710889)
Timeframe: Baseline (Day 1), Months 1 and 3

Intervention	ng/mL (Median)
	Baseline	Change at Month 1	Change at Month 3
Abaloparatide	0.460	0.052	0.311

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Change From Baseline in Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Envelope at Month 3

Change in dynamic histomorphometry indices was assessed in the cancellous envelope. (NCT03710889)
Timeframe: Baseline (Day 1), Month 3

Intervention	percentage of MS/BS (Mean)
	Baseline	Change at Month 3
Abaloparatide	5.74	18.66

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Change From Baseline in Bone Formation Rate/Bone Surface (BFR/BS) in the Cancellous Envelope at Month 3

Change in dynamic histomorphometry indices was assessed in the cancellous envelope. BFR/BS was reported as cubic millimeter/square millimeter/year (mm^3/mm^2/year). (NCT03710889)
Timeframe: Baseline (Day 1), Month 3

Intervention	mm^3/mm^2/year (Mean)
	Baseline	Change at Month 3
Abaloparatide	0.011	0.034

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Percent Change From Baseline in Femoral Neck BMD at Month 12

Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory. (NCT04064411)
Timeframe: Baseline, Month 12

Intervention	percent change (Least Squares Mean)
Abaloparatide-SC	3.4159
Abaloparatide-sMTS	1.9163

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Percent Change From Baseline in Lumbar Spine BMD at Month 12

Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory. (NCT04064411)
Timeframe: Baseline, Month 12

Intervention	percent change (Least Squares Mean)
Abaloparatide-SC	10.8571
Abaloparatide-sMTS	7.1361

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Percent Change From Baseline in Total Hip BMD at Month 12

Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory. (NCT04064411)
Timeframe: Baseline, Month 12

Intervention	percent change (Least Squares Mean)
Abaloparatide-SC	3.6995
Abaloparatide-sMTS	1.9688

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Change From Baseline of Serum Phosphorus to Predose and Postdose on Day 29

(NCT04366726)
Timeframe: Baseline, 0 (predose) and 4 hours postdose on Day 29

Intervention	mmol/L (Mean)
	Day 29, predose	Day 29, postdose
Abaloparatide-sMTS	0.051	0.006

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Change From Baseline of Serum Calcium (Albumin-Corrected) to Predose and Postdose on Day 29

(NCT04366726)
Timeframe: Baseline, 0 (predose) and 4 hours postdose on Day 29

Intervention	millimoles/liter (mmol/L) (Mean)
	Day 29, predose	Day 29, postdose
Abaloparatide-sMTS	-0.031	-0.002

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Percent Change From Baseline of Serum Procollagen Type I N-Terminal Propeptides (s-PINP) at Day 29

Intervention	percent change (Mean)
Abaloparatide-sMTS	103.16

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Change From Baseline of Cyclic Adenosine Monophosphate (cAMP) to Day 29

(NCT04366726)
Timeframe: Baseline, 0 (predose) and 30-minutes postdose on Day 29

Intervention	micromoles/liter (μmol/L) (Mean)
	Day 29, predose	Day 29, postdose
Abaloparatide-sMTS	-0.0030	-0.0006

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Abaloparatide Maximum Plasma Concentration (Cmax) on Day 29

(NCT04366726)
Timeframe: 0 (predose), 10 minutes, 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours postdose on Day 29

Intervention	picograms/milliliter (pg/mL) (Geometric Mean)
Abaloparatide-sMTS	399.6

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Abaloparatide Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) on Day 29

(NCT04366726)
Timeframe: 0 (predose) and 4 hours postdose on Day 29

Intervention	hour*pg/mL (Geometric Mean)
Abaloparatide-sMTS	604.7

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Substance	Relationship Strength	Studies	Trials	Classes	Roles
alendronate alendronic acid : A 1,1-bis(phosphonic acid) that is methanebis(phosphonic acid) in which the two methylene hydrogens are replaced by hydroxy and 3-aminopropyl groups.	11.18	15	8	1,1-bis(phosphonic acid); primary amino compound	bone density conservation agent; EC 2.5.1.1 (dimethylallyltranstransferase) inhibitor
metronidazole Metronidazole: A nitroimidazole used to treat AMEBIASIS; VAGINITIS; TRICHOMONAS INFECTIONS; GIARDIASIS; ANAEROBIC BACTERIA; and TREPONEMAL INFECTIONS.. metronidazole : A member of the class of imidazoles substituted at C-1, -2 and -5 with 2-hydroxyethyl, nitro and methyl groups respectively. It has activity against anaerobic bacteria and protozoa, and has a radiosensitising effect on hypoxic tumour cells. It may be given by mouth in tablets, or as the benzoate in an oral suspension. The hydrochloride salt can be used in intravenous infusions. Metronidazole is a prodrug and is selective for anaerobic bacteria due to their ability to intracellularly reduce the nitro group of metronidazole to give nitroso-containing intermediates. These can covalently bind to DNA, disrupting its helical structure, inducing DNA strand breaks and inhibiting bacterial nucleic acid synthesis, ultimately resulting in bacterial cell death.	2.17	1	0	C-nitro compound; imidazoles; primary alcohol	antiamoebic agent; antibacterial drug; antimicrobial agent; antiparasitic agent; antitrichomonal drug; environmental contaminant; prodrug; radiosensitizing agent; xenobiotic
methylprednisolone Methylprednisolone: A PREDNISOLONE derivative with similar anti-inflammatory action.. 6alpha-methylprednisolone : The 6alpha-stereoisomer of 6-methylprednisolone.	2.21	1	0	6-methylprednisolone; primary alpha-hydroxy ketone; tertiary alpha-hydroxy ketone	adrenergic agent; anti-inflammatory drug; antiemetic; environmental contaminant; neuroprotective agent; xenobiotic
thiophenes Thiophenes: A monocyclic heteroarene furan in which the oxygen atom is replaced by a sulfur.. thiophenes : Compounds containing at least one thiophene ring.	9.22	8	0	mancude organic heteromonocyclic parent; monocyclic heteroarene; thiophenes; volatile organic compound	non-polar solvent
quinazolines Quinazolines: A group of aromatic heterocyclic compounds that contain a bicyclic structure with two fused six-membered aromatic rings, a benzene ring and a pyrimidine ring.. quinazoline : A mancude organic heterobicyclic parent that is naphthalene in which the carbon atoms at positions 1 and 3 have been replaced by nitrogen atoms.. quinazolines : Any organic heterobicyclic compound based on a quinazoline skeleton and its substituted derivatives.	2.17	1	0	azaarene; mancude organic heterobicyclic parent; ortho-fused heteroarene; quinazolines
azomycin azomycin: RN given refers to parent cpd with specified locant; structure	2.17	1	0	C-nitro compound; imidazoles	antitubercular agent
phenyl acetate phenyl acetate: The ester formed between phenol and acetic acid. Don't confuse with phenylacetic acid derivatives listed under PHENYLACETATES.. phenyl acetate : An acetate ester obtained by the formal condensation of phenol with acetic acid.	2.17	1	0	benzenes; phenyl acetates
benzonidazole benzonidazole: used in treatment of Chagas' disease. benznidazole : A monocarboxylic acid amide obtained by formal condensation of the carboxy group of (2-nitroimidazol-1-yl)acetic acid with the aromatic amino group of benzylamine. Used for treatment of Chagas disease.	2.17	1	0	C-nitro compound; imidazoles; monocarboxylic acid amide	antiprotozoal drug
raloxifene hydrochloride Raloxifene Hydrochloride: A second generation selective estrogen receptor modulator (SERM) used to prevent osteoporosis in postmenopausal women. It has estrogen agonist effects on bone and cholesterol metabolism but behaves as a complete estrogen antagonist on mammary gland and uterine tissue.. raloxifene hydrochloride : A hydrochloride salt resulting from the reaction of equimolar amounts of raloxifene and hydrogen chloride.	9.41	9	0	hydrochloride	bone density conservation agent; estrogen antagonist; estrogen receptor modulator
secnidazole [no description available]	2.17	1	0	C-nitro compound; imidazoles; secondary alcohol	epitope
bazedoxifene [no description available]	9.22	8	0	phenylindole
meropenem Meropenem: A thienamycin derivative antibacterial agent that is more stable to renal dehydropeptidase I than IMIPENEM, but does not need to be given with an enzyme inhibitor such as CILASTATIN. It is used in the treatment of bacterial infections, including infections in immunocompromised patients.. meropenem : A carbapenemcarboxylic acid in which the azetidine and pyrroline rings carry 1-hydroxymethyl and in which the azetidine and pyrroline rings carry 1-hydroxymethyl and 5-(dimethylcarbamoyl)pyrrolidin-3-ylthio substituents respectively.	2.17	1	0	alpha,beta-unsaturated monocarboxylic acid; carbapenemcarboxylic acid; organic sulfide; pyrrolidinecarboxamide	antibacterial agent; antibacterial drug; drug allergen
tibolone tibolone: used in prevention of postmenopausal osteoporosis. tibolone : Estran-3-one with a double bond between positions 5 and 10, and bearing both an ethynyl group and a hydroxy group at position 17 (R-configuration). A synthetic steroid hormone drug which acts as an agonist at all five type I steroid hormone receptors, it is used in the prevention of postmenopausal osteoporosis and for treatment of endometriosis.	3.12	1	0	17beta-hydroxy steroid; terminal acetylenic compound	bone density conservation agent; hormone agonist
abt 492 WQ 3034: structure in first source	2.17	1	0
calcitriol dihydroxy-vitamin D3: as a major in vitro metabolite of 1alpha,25-dihydroxyvitamin D3, produced in primary cultures of neonatal human keratinocytes	3.01	2	0	D3 vitamins; hydroxycalciol; triol	antineoplastic agent; antipsoriatic; bone density conservation agent; calcium channel agonist; calcium channel modulator; hormone; human metabolite; immunomodulator; metabolite; mouse metabolite; nutraceutical
odanacatib odanacatib: a selective inhibitor of cathepsin K for the treatment of post-menopausal osteoporosis; structure in first source	3.19	1	0
letermovir letermovir: has antiviral activity; structure in first source	2.17	1	0
rpx7009 RPX7009: a beta-lactamase inhibitor; structure in first source	2.17	1	0
guanosine 5'-o-(3-thiotriphosphate) Guanosine 5'-O-(3-Thiotriphosphate): Guanosine 5'-(trihydrogen diphosphate), monoanhydride with phosphorothioic acid. A stable GTP analog which enjoys a variety of physiological actions such as stimulation of guanine nucleotide-binding proteins, phosphoinositide hydrolysis, cyclic AMP accumulation, and activation of specific proto-oncogenes.	3.04	1	0	nucleoside triphosphate analogue

Condition	Relationship Strength	Studies	Trials
Low Bone Density [description not available]	3.62	7	0
Bone Diseases, Metabolic Diseases that affect the METABOLIC PROCESSES of BONE TISSUE.	3.62	7	0
Intertrochanteric Fractures [description not available]	7.31	5	1
Bone Loss, Perimenopausal [description not available]	21.03	130	43
Hip Fractures Fractures of the FEMUR HEAD; the FEMUR NECK; (FEMORAL NECK FRACTURES); the trochanters; or the inter- or subtrochanteric region. Excludes fractures of the acetabulum and fractures of the femoral shaft below the subtrochanteric region (FEMORAL FRACTURES).	7.31	5	1
Osteoporosis, Postmenopausal Metabolic disorder associated with fractures of the femoral neck, vertebrae, and distal forearm. It occurs commonly in women within 15-20 years after menopause, and is caused by factors associated with menopause including estrogen deficiency.	21.03	130	43
Osteoporotic Fractures Breaks in bones resulting from low bone mass and microarchitectural deterioration characteristic of OSTEOPOROSIS.	17.57	62	38
Pericementitis [description not available]	3.52	1	0
Alveolar Bone Atrophy [description not available]	3.52	1	0
Periodontitis Inflammation and loss of connective tissues supporting or surrounding the teeth. This may involve any part of the PERIODONTIUM. Periodontitis is currently classified by disease progression (CHRONIC PERIODONTITIS; AGGRESSIVE PERIODONTITIS) instead of age of onset. (From 1999 International Workshop for a Classification of Periodontal Diseases and Conditions, American Academy of Periodontology)	8.52	1	0
Age-Related Osteoporosis [description not available]	14.97	50	10
Osteoporosis Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis.	14.97	50	10
Glenoid Labral Tears [description not available]	3.7	5	0
Rotator Cuff Injuries Injuries to the ROTATOR CUFF of the shoulder joint.	3.7	5	0
Bone Fractures [description not available]	8.2	7	2
Fractures, Bone Breaks in bones.	8.2	7	2
Benign Neoplasms [description not available]	2.6	1	0
Neoplasms New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.	2.6	1	0
Injuries, Spinal Cord [description not available]	2.6	1	0
Spinal Cord Injuries Penetrating and non-penetrating injuries to the spinal cord resulting from traumatic external forces (e.g., WOUNDS, GUNSHOT; WHIPLASH INJURIES; etc.).	2.6	1	0
Hangman Fracture [description not available]	20.12	97	28
Spinal Fractures Broken bones in the vertebral column.	20.12	97	28
Anorexia Nervosa An eating disorder that is characterized by the lack or loss of APPETITE, known as ANOREXIA. Other features include excess fear of becoming OVERWEIGHT; BODY IMAGE disturbance; significant WEIGHT LOSS; refusal to maintain minimal normal weight; and AMENORRHEA. This disorder occurs most frequently in adolescent females. (APA, Thesaurus of Psychological Index Terms, 1994)	2.25	1	0
Cardiac Failure [description not available]	7.68	4	4
Heart Failure A heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body. Heart failure can be caused by structural defects, functional abnormalities (VENTRICULAR DYSFUNCTION), or a sudden overload beyond its capacity. Chronic heart failure is more common than acute heart failure which results from sudden insult to cardiac function, such as MYOCARDIAL INFARCTION.	7.68	4	4
Diabetes Mellitus, Adult-Onset [description not available]	3.17	1	0
Diabetes Mellitus, Type 2 A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.	3.17	1	0
Bone Loss, Osteoclastic [description not available]	5.29	7	0
Chronic Kidney Diseases [description not available]	14.97	65	0
Fracture, Pathologic [description not available]	14.97	65	0
Renal Insufficiency, Chronic Conditions in which the KIDNEYS perform below the normal level for more than three months. Chronic kidney insufficiency is classified by five stages according to the decline in GLOMERULAR FILTRATION RATE and the degree of kidney damage (as measured by the level of PROTEINURIA). The most severe form is the end-stage renal disease (CHRONIC KIDNEY FAILURE). (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002)	14.97	65	0
Bone Cancer [description not available]	2.15	1	0
Osteogenic Sarcoma [description not available]	2.15	1	0
Bone Neoplasms Tumors or cancer located in bone tissue or specific BONES.	2.15	1	0
Osteosarcoma A sarcoma originating in bone-forming cells, affecting the ends of long bones. It is the most common and most malignant of sarcomas of the bones, and occurs chiefly among 10- to 25-year-old youths. (From Stedman, 25th ed)	2.15	1	0
Femur Neck Fractures [description not available]	3.53	1	1
Femoral Neck Fractures Fractures of the short, constricted portion of the thigh bone between the femur head and the trochanters. It excludes intertrochanteric fractures which are HIP FRACTURES.	3.53	1	1
Recrudescence [description not available]	3.09	1	0
Hypertrophy General increase in bulk of a part or organ due to CELL ENLARGEMENT and accumulation of FLUIDS AND SECRETIONS, not due to tumor formation, nor to an increase in the number of cells (HYPERPLASIA).	2.21	1	0
Femoral Fractures Fractures of the femur.	3.12	1	0
Milk-Alkali Syndrome [description not available]	12.36	17	16
Hypercalcemia Abnormally high level of calcium in the blood.	12.36	17	16
Injuries, Wrist [description not available]	4.92	2	1
Radius Fractures Fractures of the RADIUS.	3.59	1	1
Disease Models, Animal Naturally-occurring or experimentally-induced animal diseases with pathological processes analogous to human diseases.	2.21	1	0
Bone Diseases Diseases of BONES.	2.21	1	0
CKD-MBD [description not available]	3.12	1	0
Chronic Kidney Disease-Mineral and Bone Disorder Decalcification of bone or abnormal bone development due to chronic KIDNEY DISEASES, in which 1,25-DIHYDROXYVITAMIN D3 synthesis by the kidneys is impaired, leading to reduced negative feedback on PARATHYROID HORMONE. The resulting SECONDARY HYPERPARATHYROIDISM eventually leads to bone disorders.	3.12	1	0

abaloparatide

Description

Cross-References

Synonyms (3)

Research Excerpts

Toxicity

Dosage Studied

Research

Studies (111)

Study Types

Clinical Trials (18)

Trial Overview

Trial Outcomes

Change in Bone Mineral Density, Total Spine.

Change in Bone Mineral Density, Femoral Neck.

Change in Bone Mineral Density, Total Hip.

Change in Bone Mineral Density, Total Spine.

Change in Marker of Bone Metabolism, PINP

Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18

Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months

Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months

Number of Participants With Non-vertebral Fractures at 18 Months

Number of Participants With New Vertebral Fractures at 18 Months

Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18

Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4

Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4

Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4

Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result

Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months

Percent Change From Baseline in BMD of Forearm at 6 Months

Percent Change From Baseline in BMD of Total Hip at 6 Months

Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months

Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months

Percent Change From Baseline in Serum Osteocalcin at 6 Months

Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months

Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months

Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)

Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes

Percent Change From Baseline in Lumbar Spine BMD at Month 12

Percent of Participants Experiencing BMD Gains From Baseline of > 0%, > 3%, and > 6% at the Lumbar Spine, Femoral Neck, and Total Hip

Percent of Participants With Change in Disease Status

Percent Change in Total Hip BMD From Baseline at Month 6

Number of Participants With New Clinical Fractures

Percent Change From Baseline in Distal One-third Radius BMD at Month 12

Percent Change From Baseline in Femoral Neck BMD at Month 12

Percent Change From Baseline in Femoral Neck BMD at Month 6

Percent Change From Baseline in Lumbar Spine BMD at Month 6

Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) at Month 12

Percent Change From Baseline in Serum Procollagen Type I N-terminal Propeptide (s-PINP) at Month 12

Percent Change From Baseline in Total Hip BMD at Month 12

Percent Change From Baseline in Ultra-Distal Radius BMD at Month 12

Change in Serum Procollagen Type I N-terminal Propeptide (s-P1NP) From Baseline at Month 1 and Month 3

Change in Serum Carboxy-Terminal Cross-Linking Telopeptide of Type I Collagen (s-CTX) From Baseline at Month 1 and Month 3

Change From Baseline in Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Envelope at Month 3

Change From Baseline in Bone Formation Rate/Bone Surface (BFR/BS) in the Cancellous Envelope at Month 3

Percent Change From Baseline in Femoral Neck BMD at Month 12

Percent Change From Baseline in Lumbar Spine BMD at Month 12

Percent Change From Baseline in Total Hip BMD at Month 12

Change From Baseline of Serum Phosphorus to Predose and Postdose on Day 29

Change From Baseline of Serum Calcium (Albumin-Corrected) to Predose and Postdose on Day 29

Percent Change From Baseline of Serum Procollagen Type I N-Terminal Propeptides (s-PINP) at Day 29

Change From Baseline of Cyclic Adenosine Monophosphate (cAMP) to Day 29

Abaloparatide Maximum Plasma Concentration (Cmax) on Day 29

Abaloparatide Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) on Day 29

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Related Conditions (48)