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

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ClinicalTrials.gov Identifier: NCT01674621
Recruitment Status : Completed
First Posted : August 29, 2012
Results First Posted : December 19, 2016
Last Update Posted : June 16, 2020
Sponsor:
Collaborator:
Nordic Bioscience A/S
Information provided by (Responsible Party):
Radius Health, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Post Menopausal Osteoporosis Drug: Abaloparatide Transdermal (50 mcg) Drug: Abaloparatide Transdermal (100 mcg) Drug: Abaloparatide Transdermal (150 mcg) Drug: Abaloparatide Injection (80 mcg) Drug: Abaloparatide Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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.
Primary Purpose: Treatment
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
Actual Study Start Date : September 25, 2012
Actual Primary Completion Date : August 2, 2013
Actual Study Completion Date : August 2, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arms and Interventions
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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 Name: 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 Name: 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 Name: 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 Name: 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 Name: BA058 Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months [ Time Frame: Baseline, 6 Months ]
  4. Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months [ Time Frame: Baseline, 6 Months ]
  5. Percent Change From Baseline in Serum Osteocalcin at 6 Months [ Time Frame: Baseline, 6 Months ]
  6. Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months [ Time Frame: Baseline, 6 Months ]
  7. Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months [ Time Frame: Baseline, 6 Months ]
  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01674621


Locations
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United States, Colorado
Lakewood, Colorado, United States, 80227
United States, Georgia
Atlanta, Georgia, United States, 30319
United States, Maryland
Bethesda, Maryland, United States, 20817
Denmark
Aalborg, Denmark
Ballerup, Denmark
Vejle, Denmark
Estonia
Tallinn, Estonia
Poland
Lodz, Poland
Warsaw, Poland
Sponsors and Collaborators
Radius Health, Inc.
Nordic Bioscience A/S
More Information
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Responsible Party: Radius Health, Inc.
ClinicalTrials.gov Identifier: NCT01674621    
Other Study ID Numbers: BA058-05-007
2012-001921-29 ( EudraCT Number )
First Posted: August 29, 2012    Key Record Dates
Results First Posted: December 19, 2016
Last Update Posted: June 16, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Radius Health, Inc.:
BA058
Abaloparatide-SC
abaloparatide
Abaloparatide-TD
 Osteo
Osteoporosis
Transdermal
Patch
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
 Abaloparatide
Parathyroid Hormone-Related Protein
Bone Density Conservation Agents
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents