Skip to main content
OpenTrials
Completed

NCT Number: NCT01674621

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post Menopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

Up to 85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Aalborg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Abaloparatide Transdermal (50 mcg)

Drug

Abaloparatide Transdermal Microneedle Active Patch

Other names: BA058 Transdermal (50 mcg)

Abaloparatide Transdermal (100 mcg)

Drug

Abaloparatide Transdermal Microneedle Active Patch

Other names: BA058 Transdermal (100 mcg)

Abaloparatide Transdermal (150 mcg)

Drug

Abaloparatide Transdermal Microneedle Active Patch

Other names: BA058 Transdermal (150 mcg)

Abaloparatide Injection (80 mcg)

Drug

Abaloparatide Subcutaneous Injection

Other names: BA058 Injection (80 mcg)

Abaloparatide Placebo

Drug

Abaloparatide Transdermal Microneedle Placebo Patch

Other names: BA058 Placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

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

    Time frame: Baseline, 6 Months

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

    Time frame: Baseline, 6 Months

  5. Percent Change From Baseline in Serum Osteocalcin at 6 Months

    Time frame: Baseline, 6 Months

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

    Time frame: Baseline, 6 Months

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

    Time frame: Baseline, 6 Months

  8. 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.

  9. 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.

  10. 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.

  11. Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4

    Time frame: 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.

  12. Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4

    Time frame: 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.

  13. Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Radius Health, Inc.

Industry

Collaborators

  • Nordic Bioscience A/S

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 29, 2012
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.