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

Radius Health

Status and phase: Completed; Phase 2

Conditions: Post Menopausal Osteoporosis

Treatments: Drug: Abaloparatide Transdermal (100 mcg); Drug: Abaloparatide Transdermal (150 mcg); Drug: Abaloparatide Transdermal (50 mcg); Drug: Abaloparatide Placebo; Drug: Abaloparatide Injection (80 mcg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01674621

2012-001921-29 (EudraCT Number)

BA058-05-007

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: Female

Ages: Under 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

250 participants in 5 patient groups, including a placebo group

Abaloparatide Transdermal (50 mcg)

Experimental group

Description:

Abaloparatide Transdermal Microneedle Patch - 50 microgram (mcg) daily applications for up to 6 months

Treatment:

Drug: Abaloparatide Transdermal (50 mcg)

Abaloparatide Transdermal (100 mcg)

Experimental group

Description:

Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months

Treatment:

Drug: Abaloparatide Transdermal (100 mcg)

Abaloparatide Transdermal (150 mcg)

Experimental group

Description:

Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months

Treatment:

Drug: Abaloparatide Transdermal (150 mcg)

Abaloparatide Injection (80 mcg)

Active Comparator group

Description:

Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months

Treatment:

Drug: Abaloparatide Injection (80 mcg)

Abaloparatide Transdermal Placebo (0 mcg)

Placebo Comparator group

Description:

Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months

Treatment:

Drug: Abaloparatide Placebo