Effects of early bridging vs normal bridging intravenous Ibandronate in the prevention of rebound effect after Denosumab discontinuation in postmenopausal osteoporosis: A randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20240713003

Enrollment

Registered

2024-07-13

Start date

2024-08-15

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Rebound effect after denosumab discontinuation in postmenopausal osteoporosis patients Postmenopausal osteoporosis Denosumab discontinuation Rebound effect

Interventions

Give Ibandronate as an early bridging dose (the first dose of Ibandronate is given 3 months after the last dose of Denosumab) then every 3 months, total 4 doses,Give Ibandronate as an normal bridging

Experimental Drug,Active Comparator Drug

Early bridging,Normal bridging

Eligibility

Sex/Gender

Female

Age

45 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Postmenopausal female patients aged 45 years and over who have been diagnosed with osteoporosis. According to the criteria of the Thai osteoporosis foundation(TOPF 2021) and clinical practice guideline from American Association of Clinical Endocrinologists(AACE 2020) 2. Have been receiving treatment with Denosumab for at least 1 year and are at risk for bone fractures decreased below a very high level after treatment (Treat to target) according to the criteria of the Thai osteoporosis foundation(TOPF 2021) and clinical practice guideline from the American Association of Clinical Endocrinologists(AACE 2020) 3. Patients experience adverse effects from Denosumab or wish to stop the drug for various reasons

Exclusion criteria

Exclusion criteria: 1. Patients with kidney function (GFR) less than 35 ml/min 2. Patients with secondary causes of osteoporosis 3. Cancer patients 4. Patients with metabolic bone disease 5. Patients with low blood calcium 6. Patients with contraindications to the use of Ibandronate 7. Patients at very high risk of bone fractures - Patients with T-score BMD < -3.5

Design outcomes

Primary

Measure	Time frame
Serum C-telopeptide (CTX) Every 3 months after denosumab discontinuation Blood test	—

Secondary

Measure	Time frame
Bone mineral density 12 months after denosumab discontinuation Bone mineral density test	—

Countries

Thailand

Contacts

Public ContactSun Aschaitrakool

Faculty of Medicine, Chulalongkorn University

sun.asc@chulahospital.org0886306600

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026