Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT04467983
PHASE4

Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone

Sponsor: Hospital for Special Surgery, New York

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

45 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2021-02-01

Completion Date

2026-12-01

Last Updated

2025-05-02

Healthy Volunteers

Yes

Interventions

DRUG

Denosumab Injection

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

DRUG

Abaloparatide

Combination therapy: 3 injections of Denosumab at appropriate times, separated by no more than 7 months from the last treatment, with added abaloparatide 80 mcg subcutaneously daily, started within 6 months of the last denosumab treatment, for a total of 18 months.

Locations (1)

Hospital for Special Surgery

New York, New York, United States