Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis

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

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 Overview

• Status: Completed
• Conditions: Post Menopausal Osteoporosis
• Intervention / Treatment: Drug: Abaloparatide Transdermal (50 mcg); Drug: Abaloparatide Transdermal (100 mcg); Drug: Abaloparatide Transdermal (150 mcg); Drug: Abaloparatide Injection (80 mcg); Drug: Abaloparatide Placebo

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark
  • Ballerup, Denmark
  • Vejle, Denmark
• Estonia
  • Tallinn, Estonia
• Poland
  • Lodz, Poland
  • Warsaw, Poland
• United States
  • Colorado
    • Lakewood, Colorado, United States, 80227
  • Georgia
    • Atlanta, Georgia, United States, 30319
  • Maryland
    • Bethesda, Maryland, United States, 20817

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abaloparatide Transdermal (50 mcg); Abaloparatide Transdermal Microneedle Patch - 50 microgram (mcg) daily applications for up to 6 months	Drug: Abaloparatide Transdermal (50 mcg); Abaloparatide Transdermal Microneedle Active Patch; Other Names: BA058 Transdermal (50 mcg)
Experimental: Abaloparatide Transdermal (100 mcg); Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months	Drug: Abaloparatide Transdermal (100 mcg); Abaloparatide Transdermal Microneedle Active Patch; Other Names: BA058 Transdermal (100 mcg)
Experimental: Abaloparatide Transdermal (150 mcg); Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months	Drug: Abaloparatide Transdermal (150 mcg); Abaloparatide Transdermal Microneedle Active Patch; Other Names: BA058 Transdermal (150 mcg)
Active Comparator: Abaloparatide Injection (80 mcg); Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months	Drug: Abaloparatide Injection (80 mcg); Abaloparatide Subcutaneous Injection; Other Names: BA058 Injection (80 mcg)
Placebo Comparator: Abaloparatide Transdermal Placebo (0 mcg); Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months	Drug: Abaloparatide Placebo; Abaloparatide Transdermal Microneedle Placebo Patch; Other Names: BA058 Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, 6 Months
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
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.	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.	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.	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.	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.	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.	Baseline up to 6 Months

Collaborators and Investigators

• Sponsor: Radius Health, Inc.
• Collaborators: Nordic Bioscience A/S

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2012
• Primary Completion (Actual): August 2, 2013
• Study Completion (Actual): August 2, 2013

Study Registration Dates

• First Submitted: August 24, 2012
• First Submitted That Met QC Criteria: August 28, 2012
• First Posted (Estimate): August 29, 2012

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Transdermal; Osteoporosis; BA058; abaloparatide; Abaloparatide-SC; Patch; Abaloparatide-TD; Osteo
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Parathyroid Hormone-Related Protein; Abaloparatide
• Other Study ID Numbers: BA058-05-007; 2012-001921-29 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided