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Zoledronic Acid to Maintain Bone Mass After Denosumab Discontinuation (AfterDmab)

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ClinicalTrials.gov Identifier: NCT02499237
Recruitment Status : Completed
First Posted : July 16, 2015
Last Update Posted : March 11, 2019
Sponsor:
Collaborators:
251 Hellenic Air Force & VA General Hospital
Leiden University Medical Center
Information provided by (Responsible Party):
Athanasios D. Anastasilakis, 424 General Military Hospital

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.

Condition or disease Intervention/treatment Phase
Postmenopausal Osteoporosis Drug: Denosumab Drug: Zoledronic acid Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Zoledronic Acid Infusion in the Bone Loss Observed Following Denosumab Discontinuation in Postmenopausal Women With Low Bone Mass
Actual Study Start Date : July 2015
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 26, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Denosumab
Patients 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
Drug: Denosumab
Treatment of low bone mass with subcutaneous injections of denosumab 60 mg every 6 months for one year
Other Name: Prolia

Experimental: Denosumab plus zoledronic acid
Patients 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
Drug: Zoledronic acid
Treatment of low bone mass with a single infusion of zoledronic acid 5 mg for one year
Other Name: Aclasta




Primary Outcome Measures :
  1. bone mineral density of the lumbar spine [ Time Frame: from 12 to 24 months ]
    differences between the 2 arms in the changes of lumbar spine bone mineral density measured by dual-energy X-ray absorptiometry


Secondary Outcome Measures :
  1. bone mineral density of the femoral neck [ Time Frame: from 12 to 24 months ]
    differences between the 2 arms in the changes of femoral neck bone mineral density measured by dual-energy X-ray absorptiometry

  2. C-terminal telopeptide of type I collagen [ Time Frame: from 12 to 15, 18, 24 months ]
    differences between the 2 arms in the changes of C-terminal telopeptide of type I collagen

  3. propeptide of procollagen type I [ Time Frame: from 12 to 15, 18, 24 months ]
    differences between the 2 arms in the changes of propeptide of procollagen type I

  4. bone mineral density of the lumbar spine [ Time Frame: from baseline to 12 months ]
    differences between the 2 arms in the changes of lumbar spine bone mineral density measured by dual-energy X-ray absorptiometry

  5. bone mineral density of the femoral neck [ Time Frame: from baseline to 12 months ]
    differences between the 2 arms in the changes of femoral neck bone mineral density measured by dual-energy X-ray absorptiometry



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02499237


Locations
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Greece
251 Airforce & VA General Hospital
Athens, Greece, 11525
424 General Military Hospital
Thessaloniki, Greece, 56429
Sponsors and Collaborators
424 General Military Hospital
251 Hellenic Air Force & VA General Hospital
Leiden University Medical Center
Investigators
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Principal Investigator: Athanasios D Anastasilakis, PhD 424 General Military Hospital, Thessaloniki, Greece
Principal Investigator: Polyzois Makras, PhD 251 Airforce and VA General Hospital

Publications:
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Responsible Party: Athanasios D. Anastasilakis, Consultant of Endocrinology, 424 General Military Hospital
ClinicalTrials.gov Identifier: NCT02499237     History of Changes
Other Study ID Numbers: AfterDmab
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Keywords provided by Athanasios D. Anastasilakis, 424 General Military Hospital:
osteoporosis
denosumab
zoledronic acid
bone mineral density
bone markers
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Zoledronic Acid
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs