Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis
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.
Timeline
- Start
- 2012-09-25
- Primary completion
- 2013-08-02
- Completion
- 2013-08-02
Outcome
Met primary endpoint
registry analysis (unspecified test); Abaloparatide Transdermal (50 mcg) vs Abaloparatide Transdermal Placebo (0 mcg); p = 0.0066; Dunnett's test NCT01674621 ↗
registry analysis (unspecified test); Abaloparatide Transdermal (100 mcg) vs Abaloparatide Transdermal Placebo (0 mcg); p = 0.0005; Dunnett's test NCT01674621 ↗
registry analysis (unspecified test); Abaloparatide Transdermal (150 mcg) vs Abaloparatide Transdermal Placebo (0 mcg); p <0.0001; Dunnett's test NCT01674621 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abaloparatide | Peptide | 50 ug | Other |
| Subject | Abaloparatide | Peptide | 80 ug | Other |
| Subject | Abaloparatide | Peptide | 100 ug | Other |
| Subject | Abaloparatide | Peptide | 150 ug | Other |