Treatment with zoledronic acid subsequent to denosumab in osteoporosis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005529-37-DK

Enrollment

Registered

2015-12-15

Start date

2016-02-29

Completion date

Unknown

Last updated

2020-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis MedDRA version: 20.0 Level: LLT Classification code 10031289 Term: Osteoporosis, unspecified System Organ Class: 100000004859

Interventions

Trade Name: Aclasta / Zoledronic acid Product Name: zoledronic acid (ZOL) Product Code: M05BA08 Pharmaceutical Form: Emulsion for infusion INN or Proposed INN: ZOLEDRONIC ACID CAS Number: 118072-93-8

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria • Postmenopausal women (postmenopausal for at least two years) • Men above 50 years • Treatment for at least two years with denosumab • Last denosumab injection less than five months ago Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: Exclusion criteria • Low-energy vertebral fracture at any time • Low-energy hip fracture within the last 12 months • BMD T-score < -2,5 (lumbar spine, total hip or femoral neck) • Alendronate treatment for more than three years prior to denosumab treatment • Ongoing treatment with glucocorticoids • Metabolic bone disease • Hormone replacement therapy • Cancer • Estimated glomerular filtration rate (eGFR) < 35 mL/min • Allergy to zoledronic acid • Hypocalcaemia • Contraindications for zoledronic acid according to the SPC

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate if infusion of zoledronic acid can prevent increases in bone turnover and bone loss in patients previously treated with denosumab and if there is difference between infusing zoledronic acid at six or nine months after the last injection with denosumab or when bone turnover is increased. ;Secondary Objective: To investigate if infusion of zoledronic acid can prevent increases in bone turnover and bone loss in patients previously treated with denosumab and if there is difference between infusing zoledronic acid at six or nine months after the last injection with denosumab or when bone turnover is increased. ;Primary end point(s): Co-primary endpoint • Change in lumbar spine BMD from baseline to 6 months after the zoledronic acid infusion. • The proportion of patients who fails to maintain BMD (total hip, femoral neck and spine). Failure is defined as = 3 % BMD loss at the lumbar spine or = 5 % BMD loss at the femoral neck or total hip. ;Timepoint(s) of evaluation of this end point: Co-primary endpoint • Change in lumbar spine BMD from baseline to 6 months after the zoledronic acid infusion. • The proportion of patients who fails to maintain BMD (total hip, femoral neck and spine). Failure is defined as = 3 % BMD loss at the lumbar spine or = 5 % BMD loss at the femoral neck or total hip.	—

Measure

Time frame

Main Objective: To investigate if infusion of zoledronic acid can prevent increases in bone turnover and bone loss in patients previously treated with denosumab and if there is difference between infusing zoledronic acid at six or nine months after the last injection with denosumab or when bone turnover is increased. ;Secondary Objective: To investigate if infusion of zoledronic acid can prevent increases in bone turnover and bone loss in patients previously treated with denosumab and if there is difference between infusing zoledronic acid at six or nine months after the last injection with denosumab or when bone turnover is increased. ;Primary end point(s): Co-primary endpoint • Change in lumbar spine BMD from baseline to 6 months after the zoledronic acid infusion. • The proportion of patients who fails to maintain BMD (total hip, femoral neck and spine). Failure is defined as = 3 % BMD loss at the lumbar spine or = 5 % BMD loss at the femoral neck or total hip. ;Timepoint(s) of evaluation of this end point: Co-primary endpoint • Change in lumbar spine BMD from baseline to 6 months after the zoledronic acid infusion. • The proportion of patients who fails to maintain BMD (total hip, femoral neck and spine). Failure is defined as = 3 % BMD loss at the lumbar spine or = 5 % BMD loss at the femoral neck or total hip.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints • Changes in total hip, femoral neck and lumbar spine BMD from baseline to one year after the zoledronic acid infusion. • Changes in total hip, femoral neck and lumbar spine BMD from baseline to two years after the zoledronic acid infusion. • Changes in trabecular bone volume fraction (bone volume/tissue volume, BV/TV) and cortical porosity measured by high-resolution peripheral quantitative computed tomography (HR-pQCT) scan at the radius and tibia from baseline to one year after the zoledronic acid infusion. • Changes in CTX and procollagen type I N-terminal propeptide (PINP) from baseline to six months after the zoledronic acid infusion. • Changes in CTX and PINP from baseline to 12 months after the zoledronic acid infusion. • Morphometric vertebral fractures assessed by vertebral fracture assessment (VFA) one and two years after the zoledronic acid infusion. ;Timepoint(s) of evaluation of this end point: • Changes in total hip, femoral neck and lumbar spine BMD from baseline to 1 year after the ZOL infusion. • Changes in total hip, femoral neck and lumbar spine BMD from baseline to 2 years after the ZOL infusion. • Changes in trabecular bone volume fraction and cortical porosity measured by HR-pQCT scan at the radius and tibia from baseline to 1 year after the ZOL infusion. • Changes in CTX and PINP from baseline to 6 months after the ZOL infusion. • Changes in CTX and PINP from baseline to 12 months after the zoledronic acid infusion. • Morphometric vertebral fractures assessed by vertebral fracture assessment (VFA) one and two years after the zoledronic acid infusion.	—

Measure

Time frame

Secondary end point(s): Secondary endpoints • Changes in total hip, femoral neck and lumbar spine BMD from baseline to one year after the zoledronic acid infusion. • Changes in total hip, femoral neck and lumbar spine BMD from baseline to two years after the zoledronic acid infusion. • Changes in trabecular bone volume fraction (bone volume/tissue volume, BV/TV) and cortical porosity measured by high-resolution peripheral quantitative computed tomography (HR-pQCT) scan at the radius and tibia from baseline to one year after the zoledronic acid infusion. • Changes in CTX and procollagen type I N-terminal propeptide (PINP) from baseline to six months after the zoledronic acid infusion. • Changes in CTX and PINP from baseline to 12 months after the zoledronic acid infusion. • Morphometric vertebral fractures assessed by vertebral fracture assessment (VFA) one and two years after the zoledronic acid infusion. ;Timepoint(s) of evaluation of this end point: • Changes in total hip, femoral neck and lumbar spine BMD from baseline to 1 year after the ZOL infusion. • Changes in total hip, femoral neck and lumbar spine BMD from baseline to 2 years after the ZOL infusion. • Changes in trabecular bone volume fraction and cortical porosity measured by HR-pQCT scan at the radius and tibia from baseline to 1 year after the ZOL infusion. • Changes in CTX and PINP from baseline to 6 months after the ZOL infusion. • Changes in CTX and PINP from baseline to 12 months after the zoledronic acid infusion. • Morphometric vertebral fractures assessed by vertebral fracture assessment (VFA) one and two years after the zoledronic acid infusion.

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Countries

Denmark

Contacts

Public ContactBente Lomholt Langdahl

Dept. of Endocrinology and Internal Medicine, Aarhus University Hospital

benlan@rm.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026