Phase 2 Study of BA058 Transdermal Delivery in Postmenopausal Women With Osteoporosis
This study is ongoing, but not recruiting participants.
Sponsor:
Radius Health, Inc.
Collaborator:
Nordic Bioscience A/S
Information provided by (Responsible Party):
Radius Health, Inc.
ClinicalTrials.gov Identifier:
NCT01674621
First received: August 24, 2012
Last updated: March 6, 2013
Last verified: March 2013
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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 Administered Via a Coated Transdermal Microarray Delivery System (BA058 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 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: BA058 Transdermal Placebo (0 mcg)
BA058 Transdermal Microneedle Patch 0 mcg daily
|
Drug: BA058 Placebo
BA058 Transdermal Microneedle Placebo Patch, 0 mcg, daily applications for 6 months
|
|
Experimental: BA058 Transdermal (50 mcg)
BA058 Transdermal Microneedle Patch - 50 mcg daily
|
Drug: BA058 Transdermal (50 mcg)
BA058 Transdermal Microneedle Active Patch, 50 mcg, daily applications for 6 months
|
|
Experimental: BA058 Transdermal (100 mcg)
BA058 Transdermal Microneedle Patch - 100 mcg daily
|
Drug: BA058 Transdermal (100 mcg)
BA058 Transdermal Microneedle Active Patch, 100 mcg, daily applications for 6 months
|
|
Experimental: BA058 Transdermal (150 mcg)
BA058 Transdermal Microneedle Patch - 150 mcg daily
|
Drug: BA058 Transdermal (150 mcg)
BA058 Transdermal Microneedle Active Patch, 150 mcg, daily applications for 6 months
|
|
Active Comparator: BA058 Injection (80 mcg)
BA058 Subcutaneous Injection - 80 mcg daily
|
Drug: BA058 Injection (80 mcg)
BA058 Subcutaneous Injection, 80 mcg, daily injections for 6 months
|
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
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 | |
| Hong Kong | |
| Hong Kong, Hong Kong | |
| 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: | March 6, 2013 |
| 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 Osteo Osteoporosis Transdermal Patch |
Additional relevant MeSH terms:
|
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on June 18, 2013