Denosumab Sequential Therapy (DST)

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National Taiwan University

Status and phase

Unknown
Phase 4

Conditions

Osteoporosis

Treatments

Drug: Denosumab
Drug: Zoledronic Acid

Study type

Interventional

Funder types

Other

Identifiers

NCT03868033
201811067MIPC

Details and patient eligibility

About

Denosumab is a potent anti-resorptive agent and is now widely used in the treatment of osteoporosis. Although denosumab has excellent effect to increase bone mass and prevent fracture in FREEDOM study with very low complications, even up to ten years, it's effect is reversible. After holding the drug, circulating denosumab levels fall rapidly, and bone resorption reaching twice baseline levels for about 6 months. How to prevent bone loss after denosumab therapy is an important issue, especially when considering the compliance, persistence, or other comorbidities of the patient. We want to verify if zoledronic acid could be used as a sequential therapy after denosumab to prevent rapid bone loss by randomized clinical trial.

Full description

Denosumab is a monoclonal antibody directed against the protein RANK-L, the principal regulator of osteoclast development. Thus, it acts as a potent anti-resorptive agent and is now widely used in the treatment of osteoporosis. Because it's easily to be used with very low risk of complications, patient has better compliance and persistence of denosumab than bisphosphonates. It's market share increasing very rapidly in Taiwan. Although denosumab has excellent effect to increase bone mass and prevent fracture in FREEDOM study with very low complications, even up to ten years, it's effect is reversible. After holding the drug, circulating denosumab levels fall rapidly, and bone resorption reaching twice baseline levels for about 6 months. Over the first 12 months off therapy, all the bone density gained on treatment is lost4. According to previous meta-analysis study, although the persistence of denosumab therapy is better than bisphosphonates, only 62% patients keep the treatment after two years. We could image how low the persistence is after five-year or ten-year treatment in the real world. How to prevent bone loss after denosumab therapy is an important issue, especially when considering the compliance, persistence, or other comorbidities of the patient. There is only one randomized controlled trial dealing with this problem, although the primary goal of the study is designed to compare the compliance and persistence1. After switching from denosumab to alendronate for one year, bone mineral density does not decrease rapidly, although there is mild elevation of bone turn over marker. We want to verify if zoledronic acid could be used as a sequential therapy after denosumab to prevent rapid bone loss by randomized clinical trial.

Enrollment

100 estimated patients

Sex

All

Ages

55 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Postmenopausal women
  • Men >50-year-old
  • After Denosumab treatment ≥ 2 years due to osteoporosis

Exclusion criteria

  • secondary osteoporosis
  • metabolic bone disease
  • cancer history
  • continuous steroid therapy
  • hormone replacement therapy
  • ever used any other kind of anti-resorptive treatment

6.estimated Glomerular filtration rate< 35 mL/min 7.allergy to Zoledronic acid 8.hypocalcaemia 9.any contraindications to use Zoledronic acid

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 4 patient groups

Continuous Denosumab
Experimental group
Description:
Continuous anti-resorptive therapy by Denosumab for 2 years
Treatment:
Drug: Denosumab
Zoledronic acid to Denosumab
Experimental group
Description:
treat with Zoledronic acid for one year and then shift to Denosumab for another one year
Treatment:
Drug: Zoledronic Acid
Drug: Denosumab
Continuous Zoledronic acid
Experimental group
Description:
Continuous anti-resorptive therapy by Zoledronic acid for 2 years
Treatment:
Drug: Zoledronic Acid
Zoledronic acid to observation
Experimental group
Description:
treat with Zoledronic acid for one year and then close follow up by bone turn over marker. resume another dose of Zoledronic acid if elevated CTX level above normal range
Treatment:
Drug: Zoledronic Acid

Trial contacts and locations

0

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Central trial contact

Shau-Huai Fu

Data sourced from clinicaltrials.gov

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