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Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone

NCT04467983 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-05-02

No results posted yet for this study

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.

Conditions

  • Osteoporosis, Postmenopausal

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.

Sponsors & Collaborators

  • Radius Health, Inc.

    collaborator INDUSTRY

  • Crozer-Keystone Health System

    collaborator OTHER

  • Hospital for Special Surgery, New York

    lead OTHER

Principal Investigators

  • Jeri W Nieves, PhD · Hospital for Special Surgery, New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2026-09-01
Completion
2026-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04467983 on ClinicalTrials.gov