Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone
Status:
Recruiting
Trial end date:
2023-01-01
Target enrollment:
Participant gender:
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.