Zoledronic Acid to Maintain Bone Mass After Denosumab Discontinuation

Phase 4

Completed

• Conditions: Postmenopausal Osteoporosis
• Interventions: Drug: Denosumab; Drug: Zoledronic acid

• Registration Number: NCT02499237
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-14
• Study First Submitted QC: 2015-07-14
• Study First Posted: 2015-07-16
• Primary Completion: 2018-11
• Study Completion: 2018-11-26
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-08
• Last Update Posted: 2019-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Denosumab	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
Denosumab plus zoledronic acid	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

Primary Outcome Measures

Name	Time	Method
bone mineral density of the lumbar spine	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

Name	Time	Method
bone mineral density of the femoral neck	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
C-terminal telopeptide of type I collagen	from 12 to 15, 18, 24 months	differences between the 2 arms in the changes of C-terminal telopeptide of type I collagen
propeptide of procollagen type I	from 12 to 15, 18, 24 months	differences between the 2 arms in the changes of propeptide of procollagen type I
bone mineral density of the lumbar spine	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

Trial Locations

Locations (2)

251 Airforce & VA General Hospital; 🇬🇷 Athens, Greece

424 General Military Hospital; 🇬🇷 Thessaloniki, Greece