Back to resultsPhase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis
Primary Purpose
Post Menopausal Osteoporosis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Abaloparatide Transdermal (50 mcg)
Abaloparatide Transdermal (100 mcg)
Abaloparatide Transdermal (150 mcg)
Abaloparatide Injection (80 mcg)
Abaloparatide Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Post Menopausal Osteoporosis focused on measuring BA058, Abaloparatide-SC, abaloparatide, Abaloparatide-TD, Osteo, Osteoporosis, Transdermal, Patch
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
Abaloparatide Transdermal (50 mcg)
Abaloparatide Transdermal (100 mcg)
Abaloparatide Transdermal (150 mcg)
Abaloparatide Injection (80 mcg)
Abaloparatide Transdermal Placebo (0 mcg)
Arm Description
Abaloparatide Transdermal Microneedle Patch - 50 microgram (mcg) daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Percent Change From Baseline in BMD of Forearm at 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
Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months
Percent Change From Baseline in Serum Osteocalcin at 6 Months
Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months
Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT01674621
First Posted
August 24, 2012
Last Updated
May 28, 2020
Sponsor
Radius Health, Inc.
Collaborators
Nordic Bioscience A/S
1. Study Identification
Unique Protocol Identification Number
NCT01674621
Brief Title
Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 25, 2012 (Actual)
Primary Completion Date
August 2, 2013 (Actual)
Study Completion Date
August 2, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radius Health, Inc.
Collaborators
Nordic Bioscience A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Menopausal Osteoporosis
Keywords
BA058, Abaloparatide-SC, abaloparatide, Abaloparatide-TD, Osteo, Osteoporosis, Transdermal, Patch
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abaloparatide Transdermal (50 mcg)
Arm Type
Experimental
Arm Description
Abaloparatide Transdermal Microneedle Patch - 50 microgram (mcg) daily applications for up to 6 months
Arm Title
Abaloparatide Transdermal (100 mcg)
Arm Type
Experimental
Arm Description
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
Arm Title
Abaloparatide Transdermal (150 mcg)
Arm Type
Experimental
Arm Description
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
Arm Title
Abaloparatide Injection (80 mcg)
Arm Type
Active Comparator
Arm Description
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
Arm Title
Abaloparatide Transdermal Placebo (0 mcg)
Arm Type
Placebo Comparator
Arm Description
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
Intervention Type
Drug
Intervention Name(s)
Abaloparatide Transdermal (50 mcg)
Other Intervention Name(s)
BA058 Transdermal (50 mcg)
Intervention Description
Abaloparatide Transdermal Microneedle Active Patch
Intervention Type
Drug
Intervention Name(s)
Abaloparatide Transdermal (100 mcg)
Other Intervention Name(s)
BA058 Transdermal (100 mcg)
Intervention Description
Abaloparatide Transdermal Microneedle Active Patch
Intervention Type
Drug
Intervention Name(s)
Abaloparatide Transdermal (150 mcg)
Other Intervention Name(s)
BA058 Transdermal (150 mcg)
Intervention Description
Abaloparatide Transdermal Microneedle Active Patch
Intervention Type
Drug
Intervention Name(s)
Abaloparatide Injection (80 mcg)
Other Intervention Name(s)
BA058 Injection (80 mcg)
Intervention Description
Abaloparatide Subcutaneous Injection
Intervention Type
Drug
Intervention Name(s)
Abaloparatide Placebo
Other Intervention Name(s)
BA058 Placebo
Intervention Description
Abaloparatide Transdermal Microneedle Placebo Patch
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months
Description
Percent change in BMD as specified by dual energy x-ray absorptiometry (DXA) scans of the lumbar spine.
Time Frame
Baseline, 6 Months
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in BMD of Total Hip at 6 Months
Description
Percent change in BMD as specified by DXA scans of the total hip.
Time Frame
Baseline, 6 Months
Title
Percent Change From Baseline in BMD of Forearm at 6 Months
Description
Percent change in BMD as specified by DXA scans of the forearm.
Time Frame
Baseline, 6 Months
Title
Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months
Time Frame
Baseline, 6 Months
Title
Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months
Time Frame
Baseline, 6 Months
Title
Percent Change From Baseline in Serum Osteocalcin at 6 Months
Time Frame
Baseline, 6 Months
Title
Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months
Time Frame
Baseline, 6 Months
Title
Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months
Time Frame
Baseline, 6 Months
Title
Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
Description
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
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes
Description
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
Title
Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result
Description
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
Title
Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4
Description
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
Title
Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4
Description
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
Title
Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4
Description
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
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80227
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30319
Country
United States
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
City
Aalborg
Country
Denmark
City
Ballerup
Country
Denmark
City
Vejle
Country
Denmark
City
Tallinn
Country
Estonia
City
Lodz
Country
Poland
City
Warsaw
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis
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