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

424 General Military Hospital

Status and phase: Completed; Phase 4

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: Zoledronic acid; Drug: Denosumab

Study type: Interventional

Funder types: Other

Identifiers

NCT02499237

AfterDmab

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

Denosumab

Active Comparator group

Description:

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

Treatment:

Drug: Denosumab

Denosumab plus zoledronic acid

Experimental group

Description:

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

Treatment:

Drug: Zoledronic acid