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
2 other identifiers
interventional
250
4 countries
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2012
Shorter than P25 for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2012
CompletedFirst Posted
Study publicly available on registry
August 29, 2012
CompletedStudy Start
First participant enrolled
September 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 2, 2013
CompletedResults Posted
Study results publicly available
December 19, 2016
CompletedJune 16, 2020
May 1, 2020
10 months
August 24, 2012
October 25, 2016
May 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (13)
Percent Change From Baseline in BMD of Total Hip at 6 Months
Baseline, 6 Months
Percent Change From Baseline in BMD of Forearm at 6 Months
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
- +8 more secondary outcomes
Study Arms (5)
Abaloparatide Transdermal (50 mcg)
EXPERIMENTALAbaloparatide Transdermal Microneedle Patch - 50 microgram (mcg) daily applications for up to 6 months
Abaloparatide Transdermal (100 mcg)
EXPERIMENTALAbaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
Abaloparatide Transdermal (150 mcg)
EXPERIMENTALAbaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
Abaloparatide Injection (80 mcg)
ACTIVE COMPARATORAbaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
Abaloparatide Transdermal Placebo (0 mcg)
PLACEBO COMPARATORAbaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
Interventions
Abaloparatide Transdermal Microneedle Active Patch
Abaloparatide Transdermal Microneedle Active Patch
Abaloparatide Transdermal Microneedle Active Patch
Abaloparatide Subcutaneous Injection
Abaloparatide Transdermal Microneedle Placebo Patch
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radius Health, Inc.lead
- Nordic Bioscience A/Scollaborator
Study Sites (9)
Unknown Facility
Lakewood, Colorado, 80227, United States
Unknown Facility
Atlanta, Georgia, 30319, United States
Unknown Facility
Bethesda, Maryland, 20817, United States
Unknown Facility
Aalborg, Denmark
Unknown Facility
Ballerup Municipality, Denmark
Unknown Facility
Vejle, Denmark
Unknown Facility
Tallinn, Estonia
Unknown Facility
Lodz, Poland
Unknown Facility
Warsaw, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Program Director
- Organization
- Radius Health Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2012
First Posted
August 29, 2012
Study Start
September 25, 2012
Primary Completion
August 2, 2013
Study Completion
August 2, 2013
Last Updated
June 16, 2020
Results First Posted
December 19, 2016
Record last verified: 2020-05