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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
250
Abaloparatide Transdermal Microneedle Active Patch
Abaloparatide Transdermal Microneedle Active Patch
Abaloparatide Transdermal Microneedle Active Patch
Unnamed facility
Lakewood, Colorado, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Bethesda, Maryland, United States
Unnamed facility
Aalborg, Denmark
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
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
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
Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months
Time frame: Baseline, 6 Months
Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months
Time frame: Baseline, 6 Months
Percent Change From Baseline in Serum Osteocalcin at 6 Months
Time frame: Baseline, 6 Months
Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months
Time frame: Baseline, 6 Months
Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months
Time frame: Baseline, 6 Months
Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
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Abaloparatide Subcutaneous Injection
Abaloparatide Transdermal Microneedle Placebo Patch
Unnamed facility
Ballerup Municipality, Denmark
Unnamed facility
Vejle, Denmark
Unnamed facility
Tallinn, Estonia
Unnamed facility
Lodz, Poland
Unnamed facility
Warsaw, Poland
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
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
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
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
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
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