Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 45
Healthy Volunteers: Accepts Healthy Volunteers
View:

• 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.

Locations
United States
Pennsylvania
Osteoporosis Center of Delaware County
Recruiting
Broomall
Contact Information
Primary
Jacqi Kernaghan, PA-C
jacqueline.kernaghan@crozer.org
6109386701
Backup
Barry Jacobson, MD
barry.jacobson@crozer.org
6109386701
Time Frame
Start Date: February 1, 2021
Estimated Completion Date: January 2023
Participants
Target number of participants: 70
Treatments
Active Comparator: Denosumab alone
3 injections of Denosumab at appropriate times, separated by no more than 7 months from the last treatment.
Active Comparator: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Crozer-Keystone Health System, Radius Health, Inc.
Leads: Felicia Cosman, MD

This content was sourced from clinicaltrials.gov

Similar Clinical Trials