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Completed

NCT Number: NCT02499237

Zoledronic Acid to Maintain Bone Mass After Denosumab Discontinuation

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.

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Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

251 Airforce & VA General Hospital, Athens, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Denosumab

Drug

Treatment of low bone mass with subcutaneous injections of denosumab 60 mg every 6 months for one year

Other names: Prolia

Zoledronic acid

Drug

Treatment of low bone mass with a single infusion of zoledronic acid 5 mg for one year

Other names: Aclasta

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

424 General Military Hospital

Other

Collaborators

  • 251 Hellenic Air Force & VA General Hospital
  • Leiden University Medical Center

Registry information

Official study title

The Effect of Zoledronic Acid Infusion in the Bone Loss Observed Following Denosumab Discontinuation in Postmenopausal Women With Low Bone Mass

Acronym: AfterDmab

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 16, 2015
Registry last updated
Mar 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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