Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis 2

• Status: Not yet recruiting
• Trial end date: 2027-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

The aims of ZOLARMAB2 are fourfold. First, the investigators want to investigate if multiple infusions of zoledronate can prevent the rebound activation of bone turnover and the subsequent bone loss in patients previously treated with denosumab and if there is difference between infusing zoledronate at fixed time-points after the last injection of denosumab or when bone turnover is increased.

Second, the investigators want to investigate if bone loss will resume after controlling the rebound activation of bone turnover during the first year after denosumab discontinuation and if this can be prevented by yearly infusions of zoledronate.

Third, the investigators want to investigate the underlying pathophysiological mechanisms by investigating biochemical markers, osteoclast and osteoblast activation signals in the bone and bone marrow, and the pool of preosteoclasts/mature osteoclasts before and after treatment with zoledronate.

Fourth, the investigators want to investigate the effect of denosumab discontinuation on muscle mass and muscle strength and on insulin sensitivity.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aarhus University Hospital
• Treatments: Zoledronic Acid

Criteria

Inclusion Criteria:

• Postmenopausal women (postmenopausal for at least two years)

• Age ≥ 40 years

• Treatment for at least two years with denosumab

• Last denosumab injection less than five months ago

• At least 2 lumbar vertebrae that can be evaluated by DXA

Exclusion Criteria:

• Low-energy vertebral fracture at any time

• Low-energy hip fracture within the last 12 months

• BMD T-score < -2.0 (lumbar spine, total hip or femoral neck)

• Bisphosphonate treatment for more than three years prior to denosumab treatment

• Diabetes Mellitus

• Ongoing treatment with systemic glucocorticoids

• Metabolic bone disease (for example osteogenesis imperfecta, Paget's disease of bone)

• Hormone replacement therapy

• Active cancer within the last 5 years with the exception of basal cell skin cancer

• Estimated glomerular filtration rate (eGFR) ≤ 35 mL/min

• Contraindications for zoledronate according to the SPC

• Unable to read and understand Danish