Zoledronic Acid to Maintain Bone Mass After Denosumab Discontinuation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2018-11-26

Brief Summary

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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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Detailed Description

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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.

Conditions

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Postmenopausal Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Denosumab

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Zoledronic acid

Intervention Type DRUG

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

Interventions

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Denosumab

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

Intervention Type DRUG

Zoledronic acid

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

Intervention Type DRUG

Other Intervention Names

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Prolia Aclasta

Eligibility Criteria

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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)

Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No