Clinical trial NCT01674621: Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post Menopausal Osteoporosis
Keywords: BA058
Abaloparatide-SC
abaloparatide
Abaloparatide-TD
Osteo
Osteoporosis
Transdermal
Patch
Lead sponsor: Radius Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Nordic Bioscience A/S
First posted: 2012-08-29
Enrollment: 250
Sex: FEMALE
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months
timeFrame: Baseline, 6 Months
Secondary outcomes:
measure: Percent Change From Baseline in BMD of Total Hip at 6 Months
timeFrame: Baseline, 6 Months
measure: Percent Change From Baseline in BMD of Forearm at 6 Months
timeFrame: Baseline, 6 Months
measure: Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months
timeFrame: Baseline, 6 Months
measure: Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months
timeFrame: Baseline, 6 Months
measure: Percent Change From Baseline in Serum Osteocalcin at 6 Months
timeFrame: Baseline, 6 Months
measure: Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months
timeFrame: Baseline, 6 Months
measure: Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months
timeFrame: Baseline, 6 Months
measure: Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
timeFrame: Baseline up to 6 Months
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes
timeFrame: Baseline up to 7 Months
measure: Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result
timeFrame: Baseline up to 7 Months
measure: Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4
timeFrame: Baseline up to 6 Months
measure: Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4
timeFrame: Baseline up to 6 Months
measure: Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4
timeFrame: Baseline up to 6 Months
Other outcomes:
Locations:
city: Lakewood
country: United States
state: Colorado
city: Atlanta
country: United States
state: Georgia
city: Bethesda
country: United States
state: Maryland
city: Aalborg
country: Denmark
city: Ballerup
country: Denmark
city: Vejle
country: Denmark
city: Tallinn
country: Estonia
city: Lodz
country: Poland
city: Warsaw
country: Poland
Study officials:
References: