Zoledronic Acid to Maintain Bone Mass After Denosumab Discontinuation
AfterDmab
The Effect of Zoledronic Acid Infusion in the Bone Loss Observed Following Denosumab Discontinuation in Postmenopausal Women With Low Bone Mass
1 other identifier
interventional
57
1 country
2
Brief Summary
In contrast with bisphosphonates,discontinuation of denosumab results in gradual loss of bone mineral density gains. The investigators aim to evaluate whether in patients treated with denosumab, a single zoledronic acid infusion would prevent the anticipated bone loss.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2015
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 14, 2015
CompletedFirst Posted
Study publicly available on registry
July 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 26, 2018
CompletedMarch 11, 2019
March 1, 2019
3.3 years
July 14, 2015
March 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
bone mineral density of the lumbar spine
differences between the 2 arms in the changes of lumbar spine bone mineral density measured by dual-energy X-ray absorptiometry
from 12 to 24 months
Secondary Outcomes (5)
bone mineral density of the femoral neck
from 12 to 24 months
C-terminal telopeptide of type I collagen
from 12 to 15, 18, 24 months
propeptide of procollagen type I
from 12 to 15, 18, 24 months
bone mineral density of the lumbar spine
from baseline to 12 months
bone mineral density of the femoral neck
from baseline to 12 months
Study Arms (2)
Denosumab
ACTIVE COMPARATORPatients with low bone mass, being treated only with denosumab in the past, who will receive another year of treatment with denosumab and subsequently discontinue treatment for one year
Denosumab plus zoledronic acid
EXPERIMENTALPatients with low bone mass, being treated only with denosumab in the past, who will receive a single infusion of zoledronic acid and subsequently discontinue treatment for another year
Interventions
Treatment of low bone mass with subcutaneous injections of denosumab 60 mg every 6 months for one year
Treatment of low bone mass with a single infusion of zoledronic acid 5 mg for one year
Eligibility Criteria
You may qualify if:
- postmenopausal women
- osteopenic (T-score \> -2.5 but \< -1.0) after treatment with denosumab
You may not qualify if:
- secondary osteoporosis;
- diseases that could affect bone metabolism;
- medications that could affect bone metabolism;
- history of any antiosteoporotic treatment other than denosumab prior to randomization
- severe liver or kidney disease (creatinine clearance \< 60ml/min/1.73m2)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- 424 General Military Hospitallead
- 251 Hellenic Air Force & VA General Hospitalcollaborator
- Leiden University Medical Centercollaborator
Study Sites (2)
251 Airforce & VA General Hospital
Athens, 11525, Greece
424 General Military Hospital
Thessaloniki, 56429, Greece
Related Publications (5)
Miller PD, Bolognese MA, Lewiecki EM, McClung MR, Ding B, Austin M, Liu Y, San Martin J. Effect of denosumab on bone density and turnover in postmenopausal women with low bone mass after long-term continued, discontinued, and restarting of therapy: a randomized blinded phase 2 clinical trial. Bone. 2008 Aug;43(2):222-229. doi: 10.1016/j.bone.2008.04.007. Epub 2008 Apr 26.
PMID: 18539106BACKGROUNDBone HG, Bolognese MA, Yuen CK, Kendler DL, Miller PD, Yang YC, Grazette L, San Martin J, Gallagher JC. Effects of denosumab treatment and discontinuation on bone mineral density and bone turnover markers in postmenopausal women with low bone mass. J Clin Endocrinol Metab. 2011 Apr;96(4):972-80. doi: 10.1210/jc.2010-1502. Epub 2011 Feb 2.
PMID: 21289258BACKGROUNDBlack DM, Bauer DC, Schwartz AV, Cummings SR, Rosen CJ. Continuing bisphosphonate treatment for osteoporosis--for whom and for how long? N Engl J Med. 2012 May 31;366(22):2051-3. doi: 10.1056/NEJMp1202623. Epub 2012 May 9. No abstract available.
PMID: 22571169BACKGROUNDWhitaker M, Guo J, Kehoe T, Benson G. Bisphosphonates for osteoporosis--where do we go from here? N Engl J Med. 2012 May 31;366(22):2048-51. doi: 10.1056/NEJMp1202619. Epub 2012 May 9. No abstract available.
PMID: 22571168BACKGROUNDAnastasilakis AD, Polyzos SA, Yavropoulou MP, Appelman-Dijkstra NM, Ntenti C, Mandanas S, Papatheodorou A, Makras P. Comparative Effect of Zoledronate at 6 Versus 18 Months Following Denosumab Discontinuation. Calcif Tissue Int. 2021 May;108(5):587-594. doi: 10.1007/s00223-020-00785-1. Epub 2021 Jan 2.
PMID: 33386953DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Athanasios D Anastasilakis, PhD
424 General Military Hospital, Thessaloniki, Greece
- PRINCIPAL INVESTIGATOR
Polyzois Makras, PhD
251 Airforce and VA General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant of Endocrinology
Study Record Dates
First Submitted
July 14, 2015
First Posted
July 16, 2015
Study Start
July 1, 2015
Primary Completion
November 1, 2018
Study Completion
November 26, 2018
Last Updated
March 11, 2019
Record last verified: 2019-03