Conditions: Post Menopausal Osteoporosis
Keywords: BA058 Abaloparatide-SC abaloparatide Abaloparatide-TD Osteo Osteoporosis Transdermal Patch
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 250
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: Abaloparatide Transdermal Microneedle Patch - 50 microgram (mcg) daily applications for up to 6 months arm 2: Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months arm 3: Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months arm 4: Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months arm 5: Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months

Interventions: intervention 1: Abaloparatide Transdermal (50 mcg) intervention 2: Abaloparatide Transdermal (100 mcg) intervention 3: Abaloparatide Transdermal (150 mcg) intervention 4: Abaloparatide Injection (80 mcg) intervention 5: Abaloparatide Placebo
Intervention descriptions: intervention 1: Abaloparatide Transdermal Microneedle Active Patch intervention 2: Abaloparatide Transdermal Microneedle Active Patch intervention 3: Abaloparatide Transdermal Microneedle Active Patch intervention 4: Abaloparatide Subcutaneous Injection intervention 5: Abaloparatide Transdermal Microneedle Placebo Patch

Protocol document: