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

Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months

Time frame · Baseline, 6 Months

Percent change in BMD as specified by dual energy x-ray absorptiometry (DXA) scans of the lumbar spine.

Percent Change From Baseline in BMD of Total Hip at 6 Months

Time frame · Baseline, 6 Months

Percent change in BMD as specified by DXA scans of the total hip.

Percent Change From Baseline in BMD of Forearm at 6 Months

Time frame · Baseline, 6 Months

Percent change in BMD as specified by DXA scans of the forearm.

Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months

Time frame · Baseline, 6 Months

Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months

Time frame · Baseline, 6 Months

Percent Change From Baseline in Serum Osteocalcin at 6 Months

Time frame · Baseline, 6 Months

Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months

Time frame · Baseline, 6 Months

Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months

Time frame · Baseline, 6 Months

Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)

Time frame · Baseline up to 6 Months

A full physical examination included, at a minimum: general appearance, skin, head/ears/eyes/nose/throat, lungs/chest, breasts, heart, abdomen, lymph nodes, musculoskeletal, extremities, and neurologic. Physical examination results that were considered abnormal were determined by the Investigator. A summary of other non-serious adverse events (AEs) and all serious AEs (SAEs), regardless of causality is located in Reported AE section.

Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes

Time frame · Baseline up to 7 Months

Vital sign parameters included respiration rate (breaths/minute), body temperature (°C), systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHg), and heart rate (bpm). Number of participants for each TEAE is presented. The same participant may be included in more than one TEAE category. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result

Time frame · Baseline up to 7 Months

The following ECG parameters were recorded: rhythm, heart rate, PR interval, QRS duration and QT/QTc. ECG results that were considered clinically meaningful were to be determined by the Investigator. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.