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

NCT01674621 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2020-06-16

Study results available
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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.

Conditions

  • Post Menopausal Osteoporosis

Interventions

DRUG

Abaloparatide Transdermal (50 mcg)

Abaloparatide Transdermal Microneedle Active Patch

DRUG

Abaloparatide Transdermal (100 mcg)

Abaloparatide Transdermal Microneedle Active Patch

DRUG

Abaloparatide Transdermal (150 mcg)

Abaloparatide Transdermal Microneedle Active Patch

DRUG

Abaloparatide Injection (80 mcg)

Abaloparatide Subcutaneous Injection

DRUG

Abaloparatide Placebo

Abaloparatide Transdermal Microneedle Placebo Patch

Sponsors & Collaborators

  • Nordic Bioscience A/S

    collaborator INDUSTRY

  • Radius Health, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-25
Primary Completion
2013-08-02
Completion
2013-08-02

Countries

  • United States
  • Denmark
  • Estonia
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01674621 on ClinicalTrials.gov