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

May 28, 2020 updated by: Radius Health, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months
Time Frame: Baseline, 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in BMD of Total Hip at 6 Months
Time Frame: Baseline, 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
Time Frame: Baseline, 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
Time Frame: Baseline, 6 Months
Baseline, 6 Months
Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months
Time Frame: Baseline, 6 Months
Baseline, 6 Months
Percent Change From Baseline in Serum Osteocalcin at 6 Months
Time Frame: Baseline, 6 Months
Baseline, 6 Months
Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months
Time Frame: Baseline, 6 Months
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
Baseline, 6 Months
Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
Time Frame: 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.
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
Time Frame: 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.
Baseline up to 7 Months
Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
Baseline up to 6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Radius Health, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nordic Bioscience A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 25, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 2, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 2, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BA058-05-007
  • 2012-001921-29 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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