Post Menopausal Osteoporosis
Conditions
Keywords
BA058, Abaloparatide-SC, abaloparatide, Abaloparatide-TD, Osteo, Osteoporosis, Transdermal, Patch
Brief summary
To determine the clinical safety and efficacy of abaloparatide transdermal in otherwise healthy postmenopausal women with osteoporosis as assessed by changes in bone mineral density (BMD) and serum markers of bone metabolism when compared to transdermal placebo and abaloparatide injection for 6 months of treatment.
Interventions
DRUGAbaloparatide Transdermal (50 mcg)
Abaloparatide Transdermal Microneedle Active Patch
DRUGAbaloparatide Transdermal (100 mcg)
Abaloparatide Transdermal Microneedle Active Patch
DRUGAbaloparatide Transdermal (150 mcg)
Abaloparatide Transdermal Microneedle Active Patch
Abaloparatide Subcutaneous Injection
DRUGAbaloparatide Placebo
Abaloparatide Transdermal Microneedle Placebo Patch
Sponsors
Nordic Bioscience A/S
Radius Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Since the abaloparatide injection arm was administered subcutaneously (SC), it was not possible to blind this arm of the study. Therefore, abaloparatide-SC was considered a reference drug, but the centralized BMD assessments and bone marker evaluations remained blinded to all treatment assignments.
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 85 Years
Healthy volunteers
No
Inclusion criteria
* Postmenopausal woman, less than 85 years old. * BMD T-score ≤-2.5 of spine or hip (femoral neck) or ≤-2.0 with previous fracture (within 5 years). * Normal physical exam, vital signs, electrocardiogram (ECG), and medical history. * Laboratory tests within the normal range, including serum calcium, Vitamin D, parathyroid hormone (PTH) (1-84), serum phosphorus, and alkaline phosphatase.
Exclusion criteria
* BMD T-score ≤-5.0 at the lumbar spine or hip. * History of bone disorders (for example, Paget's disease) other than postmenopausal osteoporosis. * Significantly impaired renal function. * History of any cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months | Baseline, 6 Months | Percent change in BMD as specified by dual energy x-ray absorptiometry (DXA) scans of the lumbar spine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in BMD of Forearm at 6 Months | Baseline, 6 Months | Percent change in BMD as specified by DXA scans of the forearm. |
| Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months | Baseline, 6 Months | — |
| Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months | Baseline, 6 Months | — |
| Percent Change From Baseline in Serum Osteocalcin at 6 Months | Baseline, 6 Months | — |
| Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months | Baseline, 6 Months | — |
| Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months | Baseline, 6 Months | — |
| Percent Change From Baseline in BMD of Total Hip at 6 Months | Baseline, 6 Months | Percent change in BMD as specified by DXA scans of the total hip. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Baseline up to 7 Months | 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. |
| Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result | Baseline up to 7 Months | 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. |
| Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4 | Baseline up to 6 Months | 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. |
| Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4 | Baseline up to 6 Months | 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. |
| Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4 | Baseline up to 6 Months | 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. |
| Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Baseline up to 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. |
Countries
Denmark, Estonia, Poland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months | 47 |
| Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months | 46 |
| Abaloparatide Transdermal (150 mcg) Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months | 43 |
| Abaloparatide Injection (80 mcg) Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months | 49 |
| Abaloparatide Transdermal Placebo (0 mcg) Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months | 46 |
| Total | 231 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 2 | 5 | 5 | 1 |
| Overall Study | Inability to Complete Study Procedures | 0 | 0 | 0 | 0 | 2 |
| Overall Study | Other than specified | 0 | 1 | 0 | 0 | 2 |
| Overall Study | Severe Abaloparatide-SC Hypersensitivity | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 5 | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | Abaloparatide Transdermal (50 mcg) | Abaloparatide Transdermal (100 mcg) | Abaloparatide Transdermal (150 mcg) | Abaloparatide Injection (80 mcg) | Abaloparatide Transdermal Placebo (0 mcg) | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 65.9 years STANDARD_DEVIATION 4.83 | 65.7 years STANDARD_DEVIATION 5.26 | 66.3 years STANDARD_DEVIATION 6.46 | 66.4 years STANDARD_DEVIATION 5.48 | 66.5 years STANDARD_DEVIATION 7.27 | 66.2 years STANDARD_DEVIATION 5.87 |
| Sex: Female, Male Female | 47 Participants | 46 Participants | 43 Participants | 49 Participants | 46 Participants | 231 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 40 / 50 | 40 / 51 | 37 / 47 | 41 / 51 | 39 / 50 |
| serious Total, serious adverse events | 0 / 50 | 2 / 51 | 2 / 47 | 4 / 51 | 1 / 50 |
Outcome results
Primary
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.
Time frame: Baseline, 6 Months
Population: mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abaloparatide Transdermal (50 mcg) | Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months | 1.87 Percent change | Standard Deviation 2.87 |
| Abaloparatide Transdermal (100 mcg) | Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months | 2.33 Percent change | Standard Deviation 2.96 |
| Abaloparatide Transdermal (150 mcg) | Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months | 2.95 Percent change | Standard Deviation 3.13 |
| Abaloparatide Injection (80 mcg) | Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months | 5.80 Percent change | Standard Deviation 4.21 |
| Abaloparatide Transdermal Placebo (0 mcg) | Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months | 0.04 Percent change | Standard Deviation 2.47 |
p-value: 0.0066Dunnett's test
p-value: 0.0005Dunnett's test
p-value: <0.0001Dunnett's test
95% CI: [-5.555, -2.305]
95% CI: [-5.104, -1.837]
95% CI: [-4.519, -1.193]
Secondary
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.
Time frame: Baseline up to 6 Months
Population: Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abaloparatide Transdermal (50 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Lungs at 6 months | 0 Participants |
| Abaloparatide Transdermal (50 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Abdomen at Screening | 7 Participants |
| Abaloparatide Transdermal (50 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Breasts at Screening | 4 Participants |
| Abaloparatide Transdermal (50 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Breasts at 6 months | 4 Participants |
| Abaloparatide Transdermal (50 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Neurologic at Screening | 0 Participants |
| Abaloparatide Transdermal (50 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | General appearance at 6 months | 0 Participants |
| Abaloparatide Transdermal (50 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Skin at Screening | 28 Participants |
| Abaloparatide Transdermal (50 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Extremities at Screening | 21 Participants |
| Abaloparatide Transdermal (50 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Columna at 6 months | 1 Participants |
| Abaloparatide Transdermal (50 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Skin at 6 months | 29 Participants |
| Abaloparatide Transdermal (50 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Extremities at 6 months | 23 Participants |
| Abaloparatide Transdermal (50 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Columna at Screening | 1 Participants |
| Abaloparatide Transdermal (50 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Head at Screening | 6 Participants |
| Abaloparatide Transdermal (50 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Neurologic at 6 months | 0 Participants |
| Abaloparatide Transdermal (50 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Lymph nodes at 6 months | 0 Participants |
| Abaloparatide Transdermal (50 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Head at 6 months | 6 Participants |
| Abaloparatide Transdermal (50 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | General appearance at Screening | 0 Participants |
| Abaloparatide Transdermal (50 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Lymph nodes at Screening | 0 Participants |
| Abaloparatide Transdermal (50 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Lungs at Screening | 0 Participants |
| Abaloparatide Transdermal (50 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Abdomen at 6 months | 6 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Abdomen at 6 months | 7 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Neurologic at 6 months | 0 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Abdomen at Screening | 8 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Skin at 6 months | 26 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Lungs at 6 months | 0 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Breasts at Screening | 7 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Neurologic at Screening | 0 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Breasts at 6 months | 7 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Columna at Screening | 3 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Head at 6 months | 4 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | General appearance at Screening | 0 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | General appearance at 6 months | 0 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Lungs at Screening | 0 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Extremities at 6 months | 10 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Extremities at Screening | 13 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Head at Screening | 3 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Skin at Screening | 24 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Lymph nodes at Screening | 0 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Columna at 6 months | 2 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Lymph nodes at 6 months | 0 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | General appearance at 6 months | 1 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | General appearance at Screening | 0 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Skin at Screening | 17 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Skin at 6 months | 16 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Head at Screening | 2 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Head at 6 months | 3 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Lungs at Screening | 0 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Lungs at 6 months | 0 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Breasts at Screening | 3 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Breasts at 6 months | 3 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Abdomen at Screening | 4 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Abdomen at 6 months | 3 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Lymph nodes at Screening | 1 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Lymph nodes at 6 months | 0 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Columna at Screening | 7 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Columna at 6 months | 7 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Extremities at Screening | 14 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Extremities at 6 months | 14 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Neurologic at Screening | 0 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Neurologic at 6 months | 0 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Head at Screening | 5 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Columna at 6 months | 3 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Neurologic at 6 months | 3 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Lymph nodes at 6 months | 0 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Breasts at 6 months | 4 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Extremities at Screening | 23 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | General appearance at Screening | 1 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | General appearance at 6 months | 1 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Lymph nodes at Screening | 0 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Skin at 6 months | 14 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Breasts at Screening | 3 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Extremities at 6 months | 25 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Neurologic at Screening | 2 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Columna at Screening | 4 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Lungs at 6 months | 1 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Abdomen at 6 months | 9 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Abdomen at Screening | 9 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Head at 6 months | 4 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Skin at Screening | 14 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Lungs at Screening | 1 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Neurologic at Screening | 1 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Abdomen at 6 months | 3 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Head at 6 months | 2 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Lymph nodes at Screening | 0 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Head at Screening | 1 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Lymph nodes at 6 months | 1 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Skin at 6 months | 17 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Columna at Screening | 1 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Skin at Screening | 21 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | General appearance at Screening | 0 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Columna at 6 months | 1 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | General appearance at 6 months | 0 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Extremities at Screening | 21 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Neurologic at 6 months | 1 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Breasts at Screening | 11 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Breasts at 6 months | 10 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Lungs at 6 months | 0 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Extremities at 6 months | 21 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Abdomen at Screening | 4 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Lungs at Screening | 1 Participants |
Secondary
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.
Time frame: Baseline up to 7 Months
Population: Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abaloparatide Transdermal (50 mcg) | Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result | 0 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result | 0 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result | 1 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result | 2 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result | 0 Participants |
Secondary
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.
Time frame: Baseline up to 6 Months
Population: Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abaloparatide Transdermal (50 mcg) | Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4 | 1 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4 | 0 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4 | 0 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4 | 0 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4 | 0 Participants |
Secondary
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.
Time frame: Baseline up to 6 Months
Population: Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abaloparatide Transdermal (50 mcg) | Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4 | 0 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4 | 0 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4 | 0 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4 | 0 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4 | 0 Participants |
Secondary
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.
Time frame: Baseline up to 6 Months
Population: Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abaloparatide Transdermal (50 mcg) | Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4 | 6 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4 | 5 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4 | 4 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4 | 1 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4 | 5 Participants |
Secondary
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.
Time frame: Baseline up to 7 Months
Population: Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abaloparatide Transdermal (50 mcg) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Dizziness | 0 Participants |
| Abaloparatide Transdermal (50 mcg) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Hypertension | 0 Participants |
| Abaloparatide Transdermal (50 mcg) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Blood Pressure Increased | 0 Participants |
| Abaloparatide Transdermal (50 mcg) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Heart Rate increased | 0 Participants |
| Abaloparatide Transdermal (50 mcg) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Dyspnoea | 0 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Dyspnoea | 0 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Blood Pressure Increased | 0 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Hypertension | 1 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Dizziness | 0 Participants |
| Abaloparatide Transdermal (100 mcg) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Heart Rate increased | 0 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Dyspnoea | 0 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Hypertension | 0 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Blood Pressure Increased | 1 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Dizziness | 0 Participants |
| Abaloparatide Transdermal (150 mcg) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Heart Rate increased | 1 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Heart Rate increased | 0 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Hypertension | 0 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Dizziness | 1 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Blood Pressure Increased | 1 Participants |
| Abaloparatide Injection (80 mcg) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Dyspnoea | 1 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Dizziness | 0 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Hypertension | 0 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Heart Rate increased | 0 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Dyspnoea | 0 Participants |
| Abaloparatide Transdermal Placebo (0 mcg) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Blood Pressure Increased | 0 Participants |
Secondary
Percent Change From Baseline in BMD of Forearm at 6 Months
Percent change in BMD as specified by DXA scans of the forearm.
Time frame: Baseline, 6 Months
Population: mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abaloparatide Transdermal (50 mcg) | Percent Change From Baseline in BMD of Forearm at 6 Months | -0.24 Percent change | Standard Deviation 2.74 |
| Abaloparatide Transdermal (100 mcg) | Percent Change From Baseline in BMD of Forearm at 6 Months | -0.16 Percent change | Standard Deviation 3.71 |
| Abaloparatide Transdermal (150 mcg) | Percent Change From Baseline in BMD of Forearm at 6 Months | 0.84 Percent change | Standard Deviation 2.96 |
| Abaloparatide Injection (80 mcg) | Percent Change From Baseline in BMD of Forearm at 6 Months | 0.33 Percent change | Standard Deviation 3.41 |
| Abaloparatide Transdermal Placebo (0 mcg) | Percent Change From Baseline in BMD of Forearm at 6 Months | 0.05 Percent change | Standard Deviation 3.18 |
p-value: 0.9493Dunnett's test
p-value: 0.9806Dunnett's test
p-value: 0.5191Dunnett's test
95% CI: [-2.168, 1.04]
95% CI: [-2.115, 1.15]
95% CI: [-1.106, 2.139]
Secondary
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.
Time frame: Baseline, 6 Months
Population: mITT population included all participants with pre-treatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abaloparatide Transdermal (50 mcg) | Percent Change From Baseline in BMD of Total Hip at 6 Months | 0.97 Percent change | Standard Deviation 1.95 |
| Abaloparatide Transdermal (100 mcg) | Percent Change From Baseline in BMD of Total Hip at 6 Months | 1.32 Percent change | Standard Deviation 1.96 |
| Abaloparatide Transdermal (150 mcg) | Percent Change From Baseline in BMD of Total Hip at 6 Months | 1.49 Percent change | Standard Deviation 1.73 |
| Abaloparatide Injection (80 mcg) | Percent Change From Baseline in BMD of Total Hip at 6 Months | 2.74 Percent change | Standard Deviation 3.05 |
| Abaloparatide Transdermal Placebo (0 mcg) | Percent Change From Baseline in BMD of Total Hip at 6 Months | -0.02 Percent change | Standard Deviation 2.39 |
p-value: 0.0547Dunnett's test
p-value: 0.0056Dunnett's test
p-value: 0.0018Dunnett's test
95% CI: [-2.864, -0.672]
95% CI: [-2.522, -0.318]
95% CI: [-2.368, -0.126]
Secondary
Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months
Time frame: Baseline, 6 Months
Population: mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abaloparatide Transdermal (50 mcg) | Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months | -4.84 Percent change | Standard Deviation 23.87 |
| Abaloparatide Transdermal (100 mcg) | Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months | 5.22 Percent change | Standard Deviation 43.66 |
| Abaloparatide Transdermal (150 mcg) | Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months | -5.52 Percent change | Standard Deviation 37.86 |
| Abaloparatide Injection (80 mcg) | Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months | 17.30 Percent change | Standard Deviation 42.76 |
| Abaloparatide Transdermal Placebo (0 mcg) | Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months | 10.23 Percent change | Standard Deviation 64.93 |
p-value: 0.2549Dunnett's test
p-value: 0.9115Dunnett's test
p-value: 0.239Dunnett's test
95% CI: [-40.501, -3.79]
95% CI: [-30.543, 6.372]
95% CI: [-41.614, -4.041]
Secondary
Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months
Time frame: Baseline, 6 Months
Population: mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abaloparatide Transdermal (50 mcg) | Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months | -2.61 Percent change | Standard Deviation 28.77 |
| Abaloparatide Transdermal (100 mcg) | Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months | 1.65 Percent change | Standard Deviation 48.66 |
| Abaloparatide Transdermal (150 mcg) | Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months | -8.22 Percent change | Standard Deviation 54.84 |
| Abaloparatide Injection (80 mcg) | Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months | 41.11 Percent change | Standard Deviation 104.12 |
| Abaloparatide Transdermal Placebo (0 mcg) | Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months | 9.42 Percent change | Standard Deviation 22.57 |
p-value: 0.3483Dunnett's test
p-value: 0.6839Dunnett's test
p-value: 0.1067Dunnett's test
95% CI: [-75.748, -11.694]
95% CI: [-71.665, -7.257]
95% CI: [-82.113, -16.555]
Secondary
Percent Change From Baseline in Serum Osteocalcin at 6 Months
Time frame: Baseline, 6 Months
Population: mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abaloparatide Transdermal (50 mcg) | Percent Change From Baseline in Serum Osteocalcin at 6 Months | -4.37 Percent change | Standard Deviation 19.36 |
| Abaloparatide Transdermal (100 mcg) | Percent Change From Baseline in Serum Osteocalcin at 6 Months | 6.67 Percent change | Standard Deviation 33.38 |
| Abaloparatide Transdermal (150 mcg) | Percent Change From Baseline in Serum Osteocalcin at 6 Months | -3.83 Percent change | Standard Deviation 22.01 |
| Abaloparatide Injection (80 mcg) | Percent Change From Baseline in Serum Osteocalcin at 6 Months | 69.54 Percent change | Standard Deviation 81.79 |
| Abaloparatide Transdermal Placebo (0 mcg) | Percent Change From Baseline in Serum Osteocalcin at 6 Months | -4.21 Percent change | Standard Deviation 27.55 |
p-value: 1Dunnett's test
p-value: 0.12Dunnett's test
p-value: 0.9998Dunnett's test
95% CI: [-96.926, -50.886]
95% CI: [-86.019, -39.725]
95% CI: [-96.927, -49.807]
Secondary
Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months
Time frame: Baseline, 6 Months
Population: mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abaloparatide Transdermal (50 mcg) | Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months | -17.26 Percent change | Standard Deviation 22.86 |
| Abaloparatide Transdermal (100 mcg) | Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months | -8.42 Percent change | Standard Deviation 29.51 |
| Abaloparatide Transdermal (150 mcg) | Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months | -16.63 Percent change | Standard Deviation 25.11 |
| Abaloparatide Injection (80 mcg) | Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months | 10.28 Percent change | Standard Deviation 72.31 |
| Abaloparatide Transdermal Placebo (0 mcg) | Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months | -6.76 Percent change | Standard Deviation 31.35 |
p-value: 0.1632Dunnett's test
p-value: 0.9834Dunnett's test
p-value: 0.2179Dunnett's test
95% CI: [-48.557, -6.525]
95% CI: [-39.835, 2.43]
95% CI: [-48.424, -5.405]
Secondary
Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months
Time frame: Baseline, 6 Months
Population: mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abaloparatide Transdermal (50 mcg) | Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months | -12.76 Percent change | Standard Deviation 26.81 |
| Abaloparatide Transdermal (100 mcg) | Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months | 1.52 Percent change | Standard Deviation 57.29 |
| Abaloparatide Transdermal (150 mcg) | Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months | -6.78 Percent change | Standard Deviation 38.91 |
| Abaloparatide Injection (80 mcg) | Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months | 97.64 Percent change | Standard Deviation 172.52 |
| Abaloparatide Transdermal Placebo (0 mcg) | Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months | -7.26 Percent change | Standard Deviation 35.49 |
95% CI: [-152.079, -56.758]
p-value: 0.8569Dunnett's test
p-value: 0.6091Dunnett's test
p-value: 0.9999Dunnett's test
95% CI: [-156.966, -63.831]
95% CI: [-142.94, -49.29]