Skip to content

The effect of three years of intravenous Zoledronate 4 mg for the treatment of post-menopausal osteoporosis: An open-labeled extension study

The effect of three years of intravenous Zoledronate 4 mg for the treatment of post-menopausal osteoporosis: An open-labeled extension study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250503008
Enrollment
28
Registered
2025-05-03
Start date
2019-07-23
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

Osteoporotic fracture significantly increase the morbidity and mortality of affected patients. Many patients are poorly compliant with their treatment because of side effects such as esophageal irritation. Therefore, intravenous bisphosphonate such as Zoledronate (ZA) is preferred in non-compliant patients. postmenopausal women, osteoporosis, zoledronate

Interventions

annual infusion of 4 mg of zoledronate over three years.
Experimental Drug
ZA 4 mg

Sponsors

None listed

Eligibility

Sex/Gender
Female
Age
45 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. postmenopausal osteoporotic women from internal medicine and rheumatology outpatient clinic, Phramongkutklao Hospital 2. osteoporosis is defined according to the WHO criteria.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of prior anti-resorptive treatments, such as bisphosphonates, estrogen replacement therapy, calcitonin, and raloxifene 2. patients with moderate to severe renal impairment (glomerular filtration rate < 35 mL/min, estimated by the CKD-EPI equation) 3. Patients with a known allergy to bisphosphonates, 4. Patients planning invasive dental surgery within 12 months after zoledronate infusion 5. Patients with a history of atrial fibrillation 6. Patients with a history of hyperparathyroidism 7. Patients with a history of vitamin D insufficiency 8. Patients with secondary osteoporosis were excluded.

Design outcomes

Primary

MeasureTime frame
Bone mineral density at 24 and 36 months after the intervention Dual energy x ray absorptiometry

Secondary

MeasureTime frame
Bone turnover markers at 24 and 36 months after the intervention P1NP and B-CTX level

Countries

Thailand

Contacts

Public ContactThunyawarin Arunthanachaikul

Phramongkutklao Hospital

thunyawarin.a@pmk.ac.th023547980

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026