NCT04467983Active, not recruitingPhase 4
Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 8 Jul 2020
- Start date
- 1 Feb 2021
- Primary completion date
- 18 Sept 2026
- Lead sponsor
- Hospital for Special Surgery, New York
- Diseases
- Osteoporosis
- NCT number
- NCT04467983
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 70
- From 1 Feb 2021 to the primary completion date, 18 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- A history of a symptomatic renal stone within the past 2 years or history of multiple symptomatic renal stones within the preceding 10 years
- Skeletal Disorders other than osteoporosis, including hypercalcemia, hyperparathyroidism, or Paget's Disease
- History of external or internal radiation therapy
- History of any cancer in past 5 years (except basal/squamous skin cancer)
- History of atypical femoral fracture
Lab values
- Use of drugs other than denosumab (within the preceding 3 months) known to affect skeletal or calcium homeostasis.
- Estimated GFR below 30 ml/min
- Unexplained elevation of Serum Alkaline Phosphatase
Other
- Fewer than 2 evaluable lumbar vertebrae
- Any contraindications to receipt of Abaloparatide or Denosumab
Who the study is looking for
- postmenopausal woman \>age 45 of any racial origin
- Participants will have received at least 4 prior denosumab treatments and be within 7 months from their last denosumab injection
- Participants are willing to participate for the duration of the study and have no physical or psychological illness that would prohibit them from participating.
- Diagnosis of osteoporosis based on bone mineral density and/or fracture criteria. Osteoporosis will be defined by bone mineral density T-Score \< -2.5 at lumbar spine (at least 2 evaluable vertebrae between L1 and L4), total hip or femoral neck. Osteoporosis will also be defined clinically in women with osteoporotic fractures within the preceding 5 years, including clinical vertebral or nonvertebral fractures or vertebral fracture confirmed by radiograph or lateral DXA VFA image, along with a DXA BMD T-Score \< -1.5 at one or more skeletal sites.
Age in the registry: 45 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital for Special Surgery Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.