Zoledronic Acid to Maintain Bone Mass After Denosumab Discontinuation
Information source: 424 General Military Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postmenopausal Osteoporosis
Intervention: Denosumab (Drug); Zoledronic acid (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: 424 General Military Hospital Official(s) and/or principal investigator(s): Athanasios D Anastasilakis, PhD, Principal Investigator, Affiliation: 424 General Military Hospital, Thessaloniki, Greece Polyzois Makras, PhD, Principal Investigator, Affiliation: 251 Airforce and VA General Hospital
Overall contact: Athanasios D Anastasilakis, PhD, Phone: +302310381697, Email: a.anastasilakis@mail.com
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.
Clinical Details
Official title: The Effect of Zoledronic Acid Infusion in the Bone Loss Observed Following Denosumab Discontinuation in Postmenopausal Women With Low Bone Mass
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: bone mineral density of the lumbar spine
Secondary outcome: bone mineral density of the femoral neckC-terminal telopeptide of type I collagen propeptide of procollagen type I bone mineral density of the lumbar spine bone mineral density of the femoral neck
Detailed description:
Discontinuation of denosumab results in a rebound rise of bone turnover markers and gradual
loss of the achieved bone mineral density gains. In contrast, bisphosphonates, such as
zoledronic acid, remain within the skeleton acting for several months or even years after
discontinuation while maintaining bone mineral density despite the cessation of treatment.
In this study, the investigators aim to evaluate changes in bone mineral density of the
lumbar spine and the femoral neck, as well as in bone turnover markers one year after
treatment discontinuation both in denosumab-treated women and in denosumab-treated women who
switched to zoledronic acid infusion one year before treatment discontinuation.
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- postmenopausal women
- osteopenic (T-score > -2. 5 but < -1. 0) after treatment with denosumab
Exclusion Criteria:
- 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)
Locations and Contacts
Athanasios D Anastasilakis, PhD, Phone: +302310381697, Email: a.anastasilakis@mail.com
251 Airforce & VA General Hospital, Athens 11525, Greece; Recruiting Polyzois Makras, PhD, Phone: +302107463606, Email: makras@internet.gr
424 General Military Hospital, Thessaloniki 56429, Greece; Recruiting Athanasios D Anastasilakis, PhD, Phone: +302310381697, Email: a.anastasilakis@gmail.com Stergios A Polyzos, PhD, Phone: +302310455780, Email: stergios@endo.gr
Additional Information
Related publications: Miller PD, Bolognese MA, Lewiecki EM, McClung MR, Ding B, Austin M, Liu Y, San Martin J; Amg Bone Loss Study Group. 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):222-9. doi: 10.1016/j.bone.2008.04.007. Epub 2008 Apr 26. Bone 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. Black 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. Whitaker 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.
Starting date: July 2015
Last updated: July 14, 2015
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