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NCT04467983 · ClinicalTrials.gov registry record · Phase 4
Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone
A Phase 4 study of Osteoporosis, Postmenopausal, sponsored by Hospital for Special Surgery, New York.
- Active
- Registry status
- Phase 4
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT04467983 is a Phase 4 study of Osteoporosis, Postmenopausal that is active but no longer recruiting, run by Hospital for Special Surgery, New York. The registered enrollment target is 70 participants, below the 3,252-participant average among 10 other Osteoporosis, Postmenopausal trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04467983, a Phase 4 study of Osteoporosis, Postmenopausal, is active but no longer recruiting, sponsored by Hospital for Special Surgery, New York.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
This randomized open label clinical trial will evaluate the effect of continued denosumab alone over 18 months versus denosumab with added abaloparatide for 18 months. 70 postmenopausal women will be enrolled over a period of 18 months. The co-primary outcomes will be group differences in bone mineral density (BMD) of the total hip and lumbar spine at 18 months. Secondary outcomes will include group differences in bone mineral density (BMD) at the femoral neck, trochanter and wrist sites at 6, 12 and 18 months, spine and total hip bone mineral density (BMD) at 6 and 12 months and trabecular bone score (TBS) at 18 months. Secondary outcomes will also include within group changes from baseline for each of these variables. Bone turnover markers will also be measured to demonstrate that PINP levels will increase with administration of abaloparatide even in the setting of ongoing denosumab, while CTX levels will remain low.
Conditions Studied
Interventions
- DRUG Abaloparatide
- DRUG Denosumab Injection
Study Locations (1)
New York
- Hospital for Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2021-02-01 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04467983
The ClinicalTrials.gov registry entry for NCT04467983 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,252-participant average among 10 other Osteoporosis, Postmenopausal trials with a reported enrollment target (98% lower). The listed sponsor is Hospital for Special Surgery, New York, which has 194 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Osteoporosis, Postmenopausal appearing as the primary indexed condition, and to 2 interventions - of which Abaloparatide is the first listed.
NCT04467983 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT04467983 about?
NCT04467983 is a clinical study titled "Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone". This randomized open label clinical trial will evaluate the effect of continued denosumab alone over 18 months versus denosumab with added abaloparatide for 18 months. 70 postmenopausal women will be enrolled over a period of 18 months. The co-primary outcomes will be group differences in bone miner...
What is the current status of trial NCT04467983?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 70 participants. The study started on 2021-02-01. Estimated completion is 2026-12-01.
What conditions does trial NCT04467983 study?
This clinical trial studies the following conditions: Osteoporosis, Postmenopausal.
What interventions are being tested in trial NCT04467983?
The interventions under investigation include: Abaloparatide (DRUG), Denosumab Injection (DRUG).
Who is sponsoring clinical trial NCT04467983?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04467983 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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