Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis
- Conditions
- Post Menopausal Osteoporosis
- Interventions
- Registration Number
- NCT01674621
- Lead Sponsor
- Radius Health, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 250
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal Microneedle Patch - 50 microgram (mcg) daily applications for up to 6 months Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months Abaloparatide Transdermal Placebo (0 mcg) Abaloparatide Placebo Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months Abaloparatide Transdermal (150 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months Abaloparatide Injection (80 mcg) Abaloparatide Injection (80 mcg) Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months Baseline, 6 Months Percent change in BMD as specified by dual energy x-ray absorptiometry (DXA) scans of the lumbar spine.
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months Baseline, 6 Months Percent Change From Baseline in BMD of Total Hip at 6 Months Baseline, 6 Months Percent change in BMD as specified by DXA scans of the total hip.
Percent Change From Baseline in Serum Osteocalcin at 6 Months Baseline, 6 Months Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months Baseline, 6 Months Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) 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.
Percent Change From Baseline in BMD of Forearm at 6 Months 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 Baseline, 6 Months Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result 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.
Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4 Baseline up to 6 Months Coagulation laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: prothrombin time (quick) (Grade 3: 1.51%-2.00%\*normal, Grade 4: \>2.00%\*normal), partial thromboplastin time (Grade 3: 2.34-3.00 seconds \[sec\], Grade 4: \>3.00 secs\*normal). A summary of other non-serious AEs and all serious AEs, 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 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 an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4 Baseline up to 6 Months Chemistry laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: sodium, potassium, chloride, inorganic phosphorus, albumin, total protein (Grade 3: 4 (+), \>1.0 g%, or \>10 g/L; Grade 4: nephrotic syndrome), glucose, blood urea nitrogen (BUN), creatinine (Grade 3: 3.1-6.0\*normal; Grade 4: \>6.0\*normal), uric acid, aspartate aminotransferase (AST) (Grade 3: 5.1-20.0 units \[U\]/L\*normal, Grade 4: \>20.0 U/L\*normal), alanine aminotransferase (ALT) (Grade 3: 5.1-20.0 U/L\*normal; Grade 4: \>20.0 U/L\*normal), gamma-glutamyltranspeptidase (GGT), creatine phosphokinase (CPK), alkaline phosphatase (Grade 3: 5.1-20.0 U/L\*normal; Grade 4: \>20.0 U/L\*normal), total bilirubin (Grade 3: 1.5-3.0\*normal; Grade 4: \>3.0\*normal), lactate dehydrogenase (LDH), cholesterol, triglycerides, total calcium. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months Baseline, 6 Months Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4 Baseline up to 6 Months Hematology laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: white blood cell (Grade 3: 1.0-1.9\*10\^9/liter \[L\]; Grade 4 \<1.0\*10\^9/L), platelets (Grade 3: 25.0-49.9\*10\^9/L; Grade 4: \<25.0\*10\^9/L), haemoglobin (Grade 3: 65.0-79.0 grams \[g\]/L or 4.0-4.9 mmol/L; Grade 4: \<65.0 g/L or \<4.0 millimole \[mmol\]/L), granulocytes/bands (Grade 3: 0.5-0.9\*10\^9/L; Grade 4: \<0.5\*10\^9/L), lymphocytes (Grade 3: 0.5-0.9\*10\^9/L; Grade 4: \<0.5 \*10\^9/L), haemorrhage (Grade 3: gross, 3 - 4 units transfusion per episode; Grade 4: massive, \> 4 units transfusion per episode). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.