Phase 2
Completed N=250
Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis
Post Menopausal Osteoporosis
Source: ClinicalTrials.gov NCT01674621 ↗
Enrolled (actual)
250
Serious AEs
3.6%
Results posted
Dec 2016
Primary outcomePrimary: Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months — 1.87; 2.33; 2.95; 5.80 Percent change — p=0.0066
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months |
1.87; 2.33; 2.95; 5.80; 0.04 | 0.0066 sig |
| SECONDARY Percent Change From Baseline in BMD of Total Hip at 6 Months |
0.97; 1.32; 1.49; 2.74; -0.02 | 0.0547 |
| SECONDARY Percent Change From Baseline in BMD of Forearm at 6 Months |
-0.24; -0.16; 0.84; 0.33; 0.05 | 0.9493 |
| SECONDARY Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months |
-4.84; 5.22; -5.52; 17.30; 10.23 | 0.2549 |
| SECONDARY Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months |
-17.26; -8.42; -16.63; 10.28; -6.76 | 0.1632 |
| SECONDARY Percent Change From Baseline in Serum Osteocalcin at 6 Months |
-4.37; 6.67; -3.83; 69.54; -4.21 | 1.0000 |
| SECONDARY Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months |
-12.76; 1.52; -6.78; 97.64; -7.26 | 0.8569 |
| SECONDARY Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months |
-2.61; 1.65; -8.22; 41.11; 9.42 | 0.3483 |
| SECONDARY Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result |
0; 0; 1; 2; 0 | — |
| SECONDARY Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4 |
6; 5; 4; 1; 5 | — |
| SECONDARY Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4 |
1; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4 |
0; 0; 0; 0; 0 | — |
Eligibility 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, Vitamin D, parathyroid hormone (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 (for example, Paget's disease) other than postmenopausal osteoporosis.
- Significantly impaired renal function.
- History of any cancer.
Data sourced from ClinicalTrials.gov (NCT01674621). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.