An Extension Study to Evaluate 24 Months of Standard-of-Care Osteoporosis Management Following Completion of 18 Months of BA058 or Placebo Treatment in Protocol BA058-05-003

Radius Health, Inc.0 sites1,139 target enrollmentNovember 20, 2012

ConditionsPostmenopausal Osteoporosis

InterventionsAlendronate

DrugsAlendronate

Overview

Phase: Phase 3
Intervention: Alendronate
Conditions: Postmenopausal Osteoporosis
Sponsor: Radius Health, Inc.
Enrollment: 1139
Primary Endpoint: Number of Participants With ≥1 New Vertebral Fracture Since Study BA058-05-003 Baseline
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to provide 24 months of standard of care data on participants previously enrolled in Study BA058-05-003 (NCT02653417).

Detailed Description

To assess the long-term effect of the anabolic drug, abaloparatide-subcutaneous (SC) versus placebo in the prevention of bone fracture after cessation of treatment. Participants who completed the 18-month Double-Blind BA058-05-003 (ACTIVE) study (NCT02653417), after receiving abaloparatide-SC or placebo, were enrolled in this extension study to receive 70 mg of alendronate (bisphosphonate) weekly for an additional 24 months. Complete details for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.

Registry

clinicaltrials.gov

Start Date

November 20, 2012

End Date

October 3, 2016

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Radius Health, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The participant was enrolled, randomized to either the abaloparatide-SC (BA058) or placebo arm, and successfully completed Study BA058-05-003 (NCT02653417).
•The participant was no more than 40 days from End-of-Treatment (Month 18) in Study BA058-05-003 (NCT02653417).

Exclusion Criteria

•Participants who were withdrawn from Study BA058-05-003 (NCT02653417) for any reason.
•Participants who experienced a treatment-related serious adverse event (SAE) during Study BA058-05-003 (NCT02653417).

Arms & Interventions

Alendronate

Participants received 70 milligrams (mg) of alendronate orally once per week beginning on Day 2 for up to 24 months after participating in Study BA058-05-003 during which participants received abaloparatide 80 micrograms (mcg) SC or abaloparatide-matching placebo daily for 18 months.

Intervention: Alendronate

Outcomes

Primary Outcomes

Number of Participants With ≥1 New Vertebral Fracture Since Study BA058-05-003 Baseline

Time Frame: Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Vertebral fractures were determined clinically and via protocol directed radiograph evaluation. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.

Secondary Outcomes

Percent Change From Study BA058-05-003 Baseline in Femoral Neck BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)(Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25))
Percent Change From Study BA058-05-003 Baseline in Lumbar Spine BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)(Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25))
Kaplan-Meier Estimated Event Rate of the First Incident of Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined)(Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25))
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only)(Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24)
Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only)(Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24)
Number of Participants With a Clinically Notable Coagulation Laboratory Value (Data From Study BA058-05-005 Only)(Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24)
Number of Participants With a Clinically Notable Urine Laboratory Value (Data From Study BA058-05-005 Only)(Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24)
Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only)(Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24)
Number of Participants With a Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined)(Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25))
Percent Change From Study BA058-05-003 Baseline in Total Hip BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)(Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25))