Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone (NCT04467983) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone
United States70 participantsStarted 2021-02-01
Plain-language 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.
Who can participate
Age range
45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Use of drugs other than denosumab (within the preceding 3 months) known to affect skeletal or calcium homeostasis.
* Fewer than 2 evaluable lumbar vertebrae
* 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
* Estimated GFR below 30 ml/min
* Any contraindications to receipt of Abaloparatide or Den…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bone mineral density changes at total hip and lumbar spine