Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Felicia Cosman, MD; Jacqueline Kernaghan
• Collaborators: Crozer-Keystone Health System; Radius Health, Inc.
• Treatments: Abaloparatide; Denosumab

Criteria

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 Denosumab

• History of any cancer in past 5 years (except basal/squamous skin cancer)

• Unexplained elevation of Serum Alkaline Phosphatase

• History of atypical femoral fracture