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

This study has been completed.
Sponsor:
Collaborator:
Nordic Bioscience A/S
Information provided by (Responsible Party):
Radius Health, Inc.
ClinicalTrials.gov Identifier:
NCT01674621
First received: August 24, 2012
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

To determine the clinical safety and efficacy of BA058 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 BA058 Injection for 6 months of treatment.


Condition Intervention Phase
Post Menopausal Osteoporosis
Drug: BA058 Placebo
Drug: BA058 Transdermal (50 mcg)
Drug: BA058 Transdermal (100 mcg)
Drug: BA058 Transdermal (150 mcg)
Drug: BA058 Injection (80 mcg)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of BA058 (Abaloparatide) Administered Via a Coated Transdermal Microarray Delivery System (BA058 Transdermal (Abaloparatide Transdermal)) in Healthy Postmenopausal Women With Osteoporosis

Resource links provided by NLM:


Further study details as provided by Radius Health, Inc.:

Primary Outcome Measures:
  • BMD (Lumbar Spine) [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Change in BMD, using DXA results; active compared to placebo.


Secondary Outcome Measures:
  • BMD (Hip and Forearm) [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Change in BMD, using DXA results; active compared to placebo.

  • Serum markers of bone formation and resorption [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change in laboratory results; active compared to placebo.

  • Safety and Tolerability [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    Physical examinations, vital signs, electrocardiograms, clinical laboratory tests, local tolerance, and adverse events.


Enrollment: 250
Study Start Date: August 2012
Study Completion Date: August 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: BA058 (abaloparatide) Transdermal Placebo (0 mcg)
BA058 (abaloparatide) Transdermal Microneedle Patch 0 mcg daily
Drug: BA058 Placebo
BA058 Transdermal Microneedle Placebo Patch, 0 mcg, daily applications for 6 months
Other Name: abaloparatide Placebo
Experimental: BA058 (abaloparatide) Transdermal (50 mcg)
BA058 (abaloparatide)Transdermal Microneedle Patch - 50 mcg daily
Drug: BA058 Transdermal (50 mcg)
BA058 Transdermal Microneedle Active Patch, 50 mcg, daily applications for 6 months
Other Name: abaloparatide Transdermal (50 mcg)
Experimental: BA058 (abaloparatide) Transdermal (100 mcg)
BA058 (abaloparatide) Transdermal Microneedle Patch - 100 mcg daily
Drug: BA058 Transdermal (100 mcg)
BA058 Transdermal Microneedle Active Patch, 100 mcg, daily applications for 6 months
Other Name: abaloparatide Transdermal (100 mcg)
Experimental: BA058 (abaloparatide) Transdermal (150 mcg)
BA058 (abaloparatide) Transdermal Microneedle Patch - 150 mcg daily
Drug: BA058 Transdermal (150 mcg)
BA058 Transdermal Microneedle Active Patch, 150 mcg, daily applications for 6 months
Other Name: abaloparatide Transdermal (150 mcg)
Active Comparator: BA058 (abaloparatide) Injection (80 mcg)
BA058 (abaloparatide-SC) Subcutaneous Injection - 80 mcg daily
Drug: BA058 Injection (80 mcg)
BA058 Subcutaneous Injection, 80 mcg, daily injections for 6 months
Other Name: abaloparatide Injection (80 mcg)

  Eligibility

Ages Eligible for Study:   up to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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, Vit D, 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 (e.g., Paget's disease) other than postmenopausal osteoporosis.
  • Significantly impaired renal function.
  • History of any cancer.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01674621

Locations
United States, Colorado
Lakewood, Colorado, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Maryland
Bethesda, Maryland, United States
Denmark
Aalborg, Denmark
Ballerup, Denmark
Vejie, Denmark
Estonia
Tallinn, Estonia
Poland
Lodz, Poland
Warsaw, Poland
Sponsors and Collaborators
Radius Health, Inc.
Nordic Bioscience A/S
  More Information

No publications provided

Responsible Party: Radius Health, Inc.
ClinicalTrials.gov Identifier: NCT01674621     History of Changes
Other Study ID Numbers: BA058-05-007, 2012-001921-29
Study First Received: August 24, 2012
Last Updated: June 25, 2014
Health Authority: Hong Kong: Department of Health
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Estonia: The State Agency of Medicine
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Ministry of Health
Romania: National Medicines Agency
United States: Food and Drug Administration

Keywords provided by Radius Health, Inc.:
BA058
Abaloparatide-SC
abaloparatide
Abaloparatide-TD
Osteo
Osteoporosis
Transdermal
Patch

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 18, 2014