Phase 4 N=61 Randomized Prevention

Treatment With Zoledronic Acid Subsequent to Denosumab in Osteoporosis

Osteoporosis

Bottom Line

View on ClinicalTrials.gov: NCT03087851 ↗

Enrolled (actual)

Serious AEs

8.2%

Results posted

Jan 2021

Primary outcome: Primary: Change in Lumbar Spine BMD From Baseline to 6 Months After the Zoledronic Acid Infusion. — -2.1; -4.3; -3.0 percentage change

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Zoledronic Acid (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Aarhus University Hospital
Primary completion: Aug 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Lumbar Spine BMD From Baseline to 6 Months After the Zoledronic Acid Infusion.	-2.1; -4.3; -3.0	—
PRIMARY Number of Participants Who Fail to Maintain BMD	10; 5; 6	—
SECONDARY Changes in BMD From Baseline to One Year After the Zoledronic Acid Infusion.	-4.8; -4.1; -4.7	—
SECONDARY Changes in BMD From Baseline to Two Years After the Zoledronic Acid Infusion.	-4.0; -4.1; -4.3	—
SECONDARY Changes in Cortical Porosity Measured by High-resolution Peripheral Quantitative Computed Tomography (HR-pQCT) Scan at the Radius and Tibia From Baseline to One Year After the Zoledronic Acid Infusion.	-2.5; -1.6; -4.2	—
SECONDARY Changes in p-CTX From Baseline to Six Months After the Zoledronic Acid Infusion.	0.60; 0.47; 0.47	—
SECONDARY Changes in p-CTX From Baseline to 12 Months After the Zoledronic Acid Infusion.	0.58; 0.40; 0.49	—
SECONDARY Morphometric Vertebral Fractures Assessed by Vertebral Fracture Assessment (VFA) One and Two Years After the Zoledronic Acid Infusion.	0; 2; 0	—

Summary

Denosumab is an antibody against receptor-activator of nuclear factor kappa-B ligand that prevents recruitment and differentiation of mature osteoclasts. Treatment markedly decrease bone resorption and fracture risk, and many patients will reach osteopenic bone mineral density (BMD) levels on treatment with denosumab. The treatment effect on bone turnover and BMD has, however, been demonstrated to be reversible. This study will show if the bone mass can be maintained by administrating zoledronic acid and if timing of the first dose of zoledronic acid after last dose of denosumab matters.

Eligibility Criteria

Inclusion Criteria

Postmenopausal women (postmenopausal for at least two years)
Men above 50 years
Treatment for at least two years with denosumab
Last denosumab injection less than five months ago

Exclusion Criteria

Low-energy vertebral fracture at any time
Low-energy hip fracture within the last 12 months
BMD T-score < -2, 5 (lumbar spine, total hip or femoral neck)
Alendronate treatment for more than three years prior to denosumab treatment
Ongoing treatment with glucocorticoids
Metabolic bone disease
Hormone replacement therapy
Cancer
Estimated glomerular filtration rate (eGFR) < 35 mL/min
Allergy to zoledronic acid
Hypocalcaemia
Contraindications for zoledronic acid according to the SPC

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03087851). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.