Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis
Post Menopausal Osteoporosis
About this trial
This is an interventional treatment trial for Post Menopausal Osteoporosis focused on measuring BA058, Abaloparatide-SC, abaloparatide, Abaloparatide-TD, Osteo, Osteoporosis, Transdermal, Patch
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Abaloparatide Transdermal (50 mcg)
Abaloparatide Transdermal (100 mcg)
Abaloparatide Transdermal (150 mcg)
Abaloparatide Injection (80 mcg)
Abaloparatide Transdermal Placebo (0 mcg)
Abaloparatide Transdermal Microneedle Patch - 50 microgram (mcg) daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months