Efficacy of Zoledronic Acid to Prevent Bone Loss Following Denosumab Discontinuation

NCT05405894 | Unknown FDA Drug

• 1 other identifier: REB21-1898
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This two-year observational, open-label clinical trial will evaluate the efficacy of a once-yearly infusion of zoledronic acid after denosumab discontinuation to maintain tissue mineral density and bone microarchitecture using high-resolution peripheral quantitative computed tomography (HR-pQCT) among post-menopausal women with osteoporosis.

Conditions

Osteoporosis; Osteoporosis, Postmenopausal; Osteopenia; Bone Loss

Outcome Measures

Primary Outcomes (2)

• Change in volumetric Bone Mineral Density (BMD)/bone microarchitecture from baseline

  High-resolution peripheral computed tomography scan (radius and tibia) will be used to quantify volumetric BMD/bone microarchitecture

  Change from Baseline (within 1-month of infusion) to 6-months and 12-months

• Change in areal Bone Mineral Density (BMD) from baseline

  Dual X-ray absorptiometry scan (lumbar spine, lateral vertebral assessment, and hip) will be used to quantify areal BMD

  Change from Baseline (within 1-month of infusion) to 6-months and 12-months

Secondary Outcomes (2)

• Fractures

  1 year

• MoJo Fracture Risk Questionnaire

  1 year

Other Outcomes (2)

• Optional further assessment of change in volumetric Bone Mineral Density (BMD)/bone microarchitecture from baseline

  Change from Baseline to 24-months

• Optional further assessment of change in areal Bone Mineral Density (BMD) from baseline

  Change from Baseline to 24-months

Interventions

Zoledronic acid DRUG

Once-yearly infusion of zoledronic acid following denosumab discontinuation

Also known as: Dr. Reddy's Zoledronic acid

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study focuses on post-menopausal, osteoporotic females, anticipating or preparing to transition off active denosumab treatment, for which they have received at least 2 prior injections, via a transition to once-yearly infusion of zoledronic acid.

You may qualify if:

• Post-menopausal females with osteoporosis
• Anticipating or preparing to transition off active denosumab treatment for osteoporosis with the use of a once-yearly infusion of zoledronic acid
• Received at least 2 injections of denosumab treatment
• Had a recent test (within 6 months) of serum creatine, calcium and phosphate

You may not qualify if:

• Any person for whom zoledronic acid would be considered contraindicated
• Pre-menopausal females
• Any person with significant chronic kidney disease (eGFR \< 50 ml/m2 at time of osteoporosis clinical assessment)
• Any person with previous adverse reactions or allergy to bisphosphonate therapies
• Any person with non-corrected hypocalcaemia
• Any person currently taking, and unable to discontinue the use of, prohibited medications including: ZOMETA, other bisphosphonate therapies, calcitonin, aminoglycosides, loop diuretics and agiogenesis inhibitors
• Any person with other history, condition, therapy, or uncontrolled intercurrent illness, which could in the opinion of the Qualified Medical Investigator affect compliance with study requirements or which would make the participant unsuitable for this study
• Any person with simultaneous participation in another interventional clinical study (e.g., Phase 1-3 clinical studies) or treatment with any investigational medicinal product within 30 days prior to screening visit

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary, McCaig Institute for Bone and Joint Health

Calgary, Alberta, T2N 4Z6, Canada

Location

Related Publications (2)

• Solling AS, Harslof T, Langdahl B. Treatment with Zoledronate Subsequent to Denosumab in Osteoporosis: a Randomized Trial. J Bone Miner Res. 2020 Oct;35(10):1858-1870. doi: 10.1002/jbmr.4098. Epub 2020 Jul 12.

  PMID: 32459005 BACKGROUND

• Anastasilakis AD, Polyzos SA, Makras P, Aubry-Rozier B, Kaouri S, Lamy O. Clinical Features of 24 Patients With Rebound-Associated Vertebral Fractures After Denosumab Discontinuation: Systematic Review and Additional Cases. J Bone Miner Res. 2017 Jun;32(6):1291-1296. doi: 10.1002/jbmr.3110. Epub 2017 Mar 13.

  PMID: 28240371 BACKGROUND

MeSH Terms

Conditions

Osteoporosis; Osteoporosis, Postmenopausal; Bone Diseases, Metabolic

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• William Brent Edwards, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 6, 2022
• Study Start: September 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: May 14, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)