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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-25

Study Completion Date

2013-08-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Post Menopausal Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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Abaloparatide Transdermal (50 mcg)

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

Group Type EXPERIMENTAL

Abaloparatide Transdermal (50 mcg)

Intervention Type DRUG

Abaloparatide Transdermal Microneedle Active Patch

Abaloparatide Transdermal (100 mcg)

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

Group Type EXPERIMENTAL

Abaloparatide Transdermal (100 mcg)

Intervention Type DRUG

Abaloparatide Transdermal Microneedle Active Patch

Abaloparatide Transdermal (150 mcg)

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

Group Type EXPERIMENTAL

Abaloparatide Transdermal (150 mcg)

Intervention Type DRUG

Abaloparatide Transdermal Microneedle Active Patch

Abaloparatide Injection (80 mcg)

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

Group Type ACTIVE_COMPARATOR

Abaloparatide Injection (80 mcg)

Intervention Type DRUG

Abaloparatide Subcutaneous Injection

Abaloparatide Transdermal Placebo (0 mcg)

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

Group Type PLACEBO_COMPARATOR

Abaloparatide Placebo

Intervention Type DRUG

Abaloparatide Transdermal Microneedle Placebo Patch

Interventions

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Abaloparatide Transdermal (50 mcg)

Abaloparatide Transdermal Microneedle Active Patch

Intervention Type DRUG

Abaloparatide Transdermal (100 mcg)

Abaloparatide Transdermal Microneedle Active Patch

Intervention Type DRUG

Abaloparatide Transdermal (150 mcg)

Abaloparatide Transdermal Microneedle Active Patch

Intervention Type DRUG

Abaloparatide Injection (80 mcg)

Abaloparatide Subcutaneous Injection

Intervention Type DRUG

Abaloparatide Placebo

Abaloparatide Transdermal Microneedle Placebo Patch

Intervention Type DRUG

Other Intervention Names

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BA058 Transdermal (50 mcg) BA058 Transdermal (100 mcg) BA058 Transdermal (150 mcg) BA058 Injection (80 mcg) BA058 Placebo

Eligibility Criteria

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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.

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No