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Radius WearABLe Study


Title A Randomized, Non-Inferiority, Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Abaloparatide-sMTS for the Treatment of Postmenopausal Women with Osteoporosis
Therapeutic Area Osteoporosis
Principal Investigator Lisa Ceglia
Min Age 50 Years
Max Age 85 Years
Gender Female
Contact Lisa Ceglia or Cindy Haviet
Lisa Ceglia: 617-636-8171 or Cindy Haviet: 617-636-3273
chaviet@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04064411

Overview

This is a phase 3, open- label, multicenter study that will evaluate whether the Abalo patch (abaloparatide-sMTS) delivered within the layers of skin (intradermally) has a similar effect as TYMLOSTM (abaloparatide) injection (subcutaneous, injection through the skin) when given for the treatment of osteoporosis in postmenopausal women at high risk for fractures. The study will also assess how safe the administration of Abalo patch is, to what extent individuals are able to tolerate the side effects that can possibly arise from either of the drug devices, and how they can affect day-to-day life for patients.

Study Details

Inclusion Criteria

  • Healthy ambulatory female from 50 to 85 years of age with postmenopausal osteoporosis
  • Postmenopausal for at least 5 years as demonstrated by a history of amenorrhea for at least 5 years
  • Serum 25-hydroxyvitamin D values must be ≥ 20 ng/mL

Exclusion Criteria

  • History of more than 4 spine fractures, mild or moderate, or any severe fractures based on Genant Semi-quantitative Scoring method on radiographic findings
  • History of bone disorders (eg, Paget’s disease) other than postmenopausal osteoporosis
  • History of Cushing’s disease, hyperthyroidism, hypo- or hyperparathyroidism, or malabsorptive syndromes within the past year

Study Requirements

The study will consist of a Screening Period (up to 2 months), a Pretreatment Period (1 week), and a Treatment Period (12 months) with a final visit 1 month after the last dose of study drug (Follow-Up/End of Study [EOS] visit); 1 month is defined as 30 days in this study. Thus, subjects will participate in the study for up to 16 months. Subjects will be randomized on Day 1 of the Treatment Period. During the Treatment Period, subjects will self-administer study drug once a day for 12 months and visit the study site on Days 1 and 14 and Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12. There will be a total of 5 blood collections for the duration of the study, 4 DXA of lumbar spine, total hip, and femoral neck, and 1 X-ray of lumbar and thoracic spine.