The Optimal Long Term Treatment Strategy of Anti-resorptive Medications

National Taiwan University

Status and phase: Active, not recruiting; Phase 4

Conditions: Osteoporosis; Bone Mineral Density

Treatments: Drug: Continuous Denosumab; Drug: Administer zoledronate and denosumab on an alternating schedule

Study type: Interventional

Funder types: Other

Identifiers

NCT05091086

202107164MINC

Details and patient eligibility

About

This study is to investigate whether the alternating use of Prolia (Denosumab) and Aclasta (Zoledronic acid) can continue to increase bone density.

Full description

This study intends to use a randomized trial to test whether the long-term treatment of Denosumab and Zoledronic acid can achieve sustained bone density progress and avoid the risk of rapid bone loss after the withdrawal of Denosumab.

Enrollment: 60 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Postmenopausal women or men over 50 years old with osteoporosis or osteopenia leading to fractures.
2. Denosumab treatment for at least two years and less than three years (up to maximum of five doses).

Exclusion criteria

1. Secondary osteoporosis.
2. Metabolic bone diseases.
3. Malignancy.
4. Continuous steroid treatment, hormone therapy or other medical treatment affecting bone metabolism.
5. Patients had ever used antiosteoporosis medications other than Dmab
6. Estimated glomerular filtration rate < 35 mL/min.
7. Allergy to Zoledronate.
8. Any other contraindications to Zoledronate use.
9. History of diagnosed hypocalcemia.
10. Age greater than 80 years.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Persistent treatment of Denosumab:

Active Comparator group

Description:

persistent denosumab for 7 years

Treatment:

Drug: Continuous Denosumab

Alternating treatment of Denosumab and Zoledronic acid

Experimental group

Description:

Alternating treatment with denosumab and zoledronic acid over a 7-year period: after entering the trial, patients received one year of zoledronic acid, followed by two years of denosumab, then switched back to zoledronic acid for one year, followed by another two years of denosumab, and finally received one more year of zoledronic acid.

Treatment:

Drug: Administer zoledronate and denosumab on an alternating schedule