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

Post Menopausal Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01674621
• Other study ID #: BA058-05-007
• Secondary ID: 2012-001921-29
• Status: Completed
• Phase: Phase 2
• Start date: September 25, 2012
• Est. completion date: August 2, 2013

Study information

• Verified date: May 2020
• Source: Radius Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: August 2, 2013
• Est. primary completion date: August 2, 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Post Menopausal Osteoporosis

Intervention

Drug:
• Abaloparatide Transdermal (50 mcg)
Abaloparatide Transdermal Microneedle Active Patch
• Abaloparatide Transdermal (100 mcg)
Abaloparatide Transdermal Microneedle Active Patch
• Abaloparatide Transdermal (150 mcg)
Abaloparatide Transdermal Microneedle Active Patch
• Abaloparatide Injection (80 mcg)
Abaloparatide Subcutaneous Injection
• Abaloparatide Placebo
Abaloparatide Transdermal Microneedle Placebo Patch

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Radius Health, Inc.	Nordic Bioscience A/S

Countries where clinical trial is conducted

United States,  Denmark,  Estonia,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months	Percent change in BMD as specified by dual energy x-ray absorptiometry (DXA) scans of the lumbar spine.	Baseline, 6 Months
Secondary	Percent Change From Baseline in BMD of Total Hip at 6 Months	Percent change in BMD as specified by DXA scans of the total hip.	Baseline, 6 Months
Secondary	Percent Change From Baseline in BMD of Forearm at 6 Months	Percent change in BMD as specified by DXA scans of the forearm.	Baseline, 6 Months
Secondary	Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months		Baseline, 6 Months
Secondary	Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months		Baseline, 6 Months
Secondary	Percent Change From Baseline in Serum Osteocalcin at 6 Months		Baseline, 6 Months
Secondary	Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months		Baseline, 6 Months
Secondary	Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months		Baseline, 6 Months
Secondary	Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (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.	Baseline up to 6 Months
Secondary	Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes	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.	Baseline up to 7 Months
Secondary	Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result	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.	Baseline up to 7 Months
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	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.	Baseline up to 6 Months
Secondary	Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4	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.	Baseline up to 6 Months
Secondary	Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4	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.	Baseline up to 6 Months