Phase 4
Completed N=61
Treatment With Zoledronic Acid Subsequent to Denosumab in Osteoporosis
Source: ClinicalTrials.gov NCT03087851 ↗Enrolled (actual)
61
Serious AEs
8.2%
Results posted
Jan 2021
Primary outcomePrimary: Change in Lumbar Spine BMD From Baseline to 6 Months After the Zoledronic Acid Infusion. — -2.1; -4.3; -3.0 percentage change
◆ Published Evidence
Highly cited
106citations · ~21 / year
Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis: A 2-Year Randomized Study.
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.
Linked Publications (2)
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Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis: A 2-Year Randomized Study.
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Treatment with Zoledronate Subsequent to Denosumab in Osteoporosis: a Randomized Trial.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT03087851) and the linked publication. 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. Informational only — not medical advice.