Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone

What Was Tested

This registered phase 4 trial tested Abaloparatide.

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.

It had two arms (groups): Denosumab alone (active comparator) and Combination therapy (active comparator).

3 injections of Denosumab at appropriate times, separated by no more than 7 months from the last treatment.

The registry classes the interventions as drug.

More on the Plan

Some women on denosumab treatment for osteoporosis remain at high risk for fracture.

These include women who sustain incident fractures on denosumab and those who have declining bone mineral density (BMD) or persistently low bone mineral density (BMD), despite treatment.

There are few options available for these patients.

After 2 years of denosumab treatment, when women are switched to teriparatide, total hip BMD remains below the baseline (at end of denosumab treatment) over the entire 2 years of teriparatide treatment (Leder Lancet 2015).

Who Took Part

70 planned participants were the target.

It was open to women only aged from 45 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Abaloparatide group and the comparison group should start out alike.

The Abaloparatide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Abaloparatide study: the participants and staff both knew the treatment.

It started in 2021-02-01 with completion listed for 2026-09-18.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Bone mineral density changes at total hip and lumbar spine (time frame: 18 months).

It also tracked 4 secondary outcomes, for example Bone mineral density changes in increments, Trabecular Bone Score changes, Within Group Increments in bone mineral density (vs baseline) and Differences in biochemical bone turnover markers.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Abaloparatide in 70 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Abaloparatide compound page, all human trials.