Phase 2 Study of BA058 Transdermal Delivery in Postmenopausal Women With Osteoporosis
| Status: | Completed |
|---|---|
| Conditions: | Osteoporosis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | August 2012 |
| End Date: | August 2013 |
| Contact: | Louis Brenner, MD |
| Email: | info@radiuspharm.com |
| Phone: | 617-551-4700 |
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
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.
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.
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