Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 4 study of Osteoporosis, Postmenopausal, sponsored by Hospital for Special Surgery, New York.
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 2,728-participant average among 12 other Osteoporosis, Postmenopausal trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Group differences in BMD increment at total hip and lumbar spine at 18 months.
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 |
What the registry record for NCT04467983 still lists
NCT04467983 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 2,728-participant average among 12 other Osteoporosis, Postmenopausal trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Osteoporosis, Postmenopausal
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 NCT04467983's enrollment target sits among peer trials
70 7th of 12 higher than 6 of 12 other Osteoporosis, Postmenopausal trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoporosis, Postmenopausal 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Combined Anabolic Therapy
RECRUITING · Phase 4
-
Comparative Antiresorptive Efficacy Discontinuation of Denosumab
ACTIVE NOT RECRUITING · Phase 4
-
Romosozumab Use to Build Skeletal Integrity
ACTIVE NOT RECRUITING · Phase 4
-
A Study Using Imaging Technology to Measure Changes in Bone Structure After Treatment With Teriparatide
COMPLETED · Phase 4
-
Carotid Artery Intima-Media Thickness Following Exposure to Raloxifene or Placebo
COMPLETED · Phase 4
-
Effects of Teriparatide or Zoledronic Acid Treatment on Bone in Postmenopausal Osteoporotic Women
COMPLETED · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00969111 · 70 participants · NA
Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy
- NCT01712620 · 70 participants · Phase 2
Spironolactone for Pulmonary Arterial Hypertension
- NCT02143830 · 70 participants · Phase 2
HSCT for Patients With Fanconi Anemia Using Risk-Adjusted Chemotherapy
- NCT02601339 · 70 participants
NIRS Monitoring in Premature Infants
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI