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NCT04064411 · ClinicalTrials.gov registry record · Phase 3
Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis
A Phase 3 study of Postmenopausal Osteoporosis, sponsored by Radius Health.
- Completed
- Registry status
- Phase 3
- Development phase
- 511
- Enrollment target
- 20
- Study locations
NCT04064411: Completed Phase 3 study of Postmenopausal Osteoporosis, sponsored by Radius Health.
NCT04064411 is a Phase 3 study of Postmenopausal Osteoporosis that has completed, run by Radius Health. The registered enrollment target is 511 participants, roughly in line with the 484-participant average among 14 other Postmenopausal Osteoporosis trials with a reported enrollment target. The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04064411, a Phase 3 study of Postmenopausal Osteoporosis, has completed, sponsored by Radius Health.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 511 participants
- Enrollment target
- 20
- Study locations
Study Summary
A 12-month study to compare the efficacy and safety of abaloparatide-solid microstructured transdermal system (sMTS) with abaloparatide-subcutaneous (SC).
Primary Outcome
Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory.
Conditions Studied
Interventions
- COMBINATION_PRODUCT abaloparatide
- COMBINATION_PRODUCT abaloparatide solid microstructured transdermal system
Study Locations (20)
California
- Advanced Clinical Research (ACR) - Rancho Paseo - Banning
- Osteoporosis Medical Center - Beverly Hills
- Clinical Trials of St. Jude Heritage Medical Group through S - Fullerton
- Allied Clinical Research - Gold River
- Marin Endocrine Care & Research, Inc. - Greenbrae
- St. Joseph Heritage Healthcare - Mission Viejo
- Northern California Institute for Bone Health Inc. - Orinda
- Alta California Medical Group, Inc. - Simi Valley
Arizona
- Arizona Arthritis & Rheumatology Research, PLLC - Research Center - Glendale - Glendale
- Arizona Arthritis & Rheumatology Research, PLLC - Mesa
- SunValley Arthritis Center Ltd. - Peoria
- Clinical Research Consortium - Tempe
Florida
- UNC School of Medicine - Boca Raton
- Bay Area Arthritis And Osteoporosis - Brandon
- Clinical Research of West Florida - Clearwater
Alabama
- University of Alabama Hospital at Birmingham - Birmingham
Alaska
- Orthopedic Physician Alaska - Rheumatology - Anchorage
Arkansas
- Arthritis & Rheumatism - Jonesboro
Colorado
- Lynn Institute of Denver - Aurora
District of Columbia
- MedStar Georgetown University Hospital - Department of Obstetrics and Gynecology - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 511 participants |
| Start Date | 2019-08-05 |
| Est. Completion | 2021-11-09 |
| Phase | Phase 3 |
What the finished NCT04064411 record still lists
NCT04064411 is an interventional study that assigns participants to a tested intervention. The registered 511 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 484-participant average among 14 other Postmenopausal Osteoporosis trials with a reported enrollment target.
The record links to 1 condition, with Postmenopausal Osteoporosis appearing as the primary indexed condition, and to 2 interventions - of which abaloparatide is the first listed.
NCT04064411 names 20 study sites across 8 states, led by California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT04064411 about?
NCT04064411 is a clinical study titled "Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis". A 12-month study to compare the efficacy and safety of abaloparatide-solid microstructured transdermal system (sMTS) with abaloparatide-subcutaneous (SC).
What is the current status of trial NCT04064411?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 511 participants. The study started on 2019-08-05. Estimated completion is 2021-11-09.
What conditions does trial NCT04064411 study?
This clinical trial studies the following conditions: Postmenopausal Osteoporosis.
What interventions are being tested in trial NCT04064411?
The interventions under investigation include: abaloparatide (COMBINATION_PRODUCT), abaloparatide solid microstructured transdermal system (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04064411?
This trial is sponsored by Radius Health, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04064411 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04064411's enrollment target sits among peer trials
511 5th of 14 higher than 10 of 14 other Postmenopausal Osteoporosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postmenopausal Osteoporosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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