Completed
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
What is being tested
Abaloparatide Transdermal (50 mcg)
+ Abaloparatide Transdermal (100 mcg)
+ Abaloparatide Transdermal (150 mcg)
Drug
Who is being recruted
Bone Diseases+4
+ Bone Diseases, Metabolic
+ Metabolic Diseases
Until 85 Years
+8 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 2
Interventional
Study Start: September 2012
Summary
Principal SponsorRadius Health, Inc.
Last updated: June 16, 2020
Sourced from a government-validated database.Claim as a partner
Study start date: September 25, 2012
Actual date on which the first participant was enrolled.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.
Principal SponsorRadius Health, Inc.
Last updated: June 16, 2020
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
250 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Female
Biological sex of participants that are eligible to enroll.Until 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Bone DiseasesBone Diseases, MetabolicMetabolic DiseasesMusculoskeletal DiseasesNutritional and Metabolic DiseasesOsteoporosisOsteoporosis, Postmenopausal
Criteria
4 inclusion criteria required to participate
BMD T-score <= -2.5 of spine or hip (femoral neck) or <= -2.0 with previous fracture (within 5 years)
Laboratory tests within the normal range, including serum calcium, Vitamin D, parathyroid hormone (PTH) (1-84), serum phosphorus, and alkaline phosphatase
Normal physical exam, vital signs, electrocardiogram (ECG), and medical history
Postmenopausal woman, less than 85 years old
4 exclusion criteria prevent from participating
BMD T-score <= -5.0 at the lumbar spine or hip
History of any cancer
History of bone disorders (for example, Paget's disease) other than postmenopausal osteoporosis
Significantly impaired renal function
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
5 intervention groups are designated in this study
20% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalAbaloparatide Transdermal Microneedle Patch - 50 microgram (mcg) daily applications for up to 6 months
Group II
ExperimentalAbaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
Group III
ExperimentalAbaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
Group IV
Active ComparatorAbaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
Group 5
PlaceboAbaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 9 locations
Lakewood, United StatesOpen in Google Maps
Atlanta, United States
Bethesda, United States
Aalborg, Denmark
Completed9 Study Centers