Skip to content

Low Dose Intravenous Zoledronate for the Treatment of Post-menopausal Osteoporosis: a prospective open-labeled study

Low Dose Intravenous Zoledronate for the Treatment of Post-menopausal Osteoporosis: a prospective open-labeled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210930001
Enrollment
36
Registered
2021-09-30
Start date
2018-07-01
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

Postmenopausal osteoporosis postmenopausal osteoporosis, zoledronate, bone mineral density, fracture, prevention

Interventions

A single dose of 4 mg of Zoledronate given as a 15 to 30 minutes intravenous infusion in 100 mL of 0.9% NaCl. Each vial (5 mL) contains Zoledronic acid monohydrate equivalent to Zoledronic acid anhydr
Experimental Drug
zoledronate

Sponsors

Phramongkutklao hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 90 Years

Inclusion criteria

Inclusion criteria: postmenopausal osteoporotic women from the Internal Medicine and Rheumatology Outpatient Clinic, Phramongkutklao Hospital between July 2018 and December 2019. In all the women, menopause had occurred at least five years previously, either naturally or as the result of bilateral oophorectomy. Osteoporosis is defined according to the WHO criteria, as a BMD either at the lumbar spine or hip of less than 2.5 standard deviations or more below the average value for young healthy women (a T-score of <-2.5 SD).

Exclusion criteria

Exclusion criteria: patients who previously received anti-resorptive treatment including bisphosphonate, estrogen replacement therapy, calcitonin and raloxifene, moderate to severe renal impairment (GFR < 35 mL/min estimated by CKD-EPI equation,8 allergic to bisphosphonates, planning for invasive dental surgery within 12 months after Zoledronate infusion, history of atrial fibrillation, history of hyperparathyroidism, vitamin D insufficiency and evidence of secondary osteoporosis.

Design outcomes

Primary

MeasureTime frame
Lumbar bone mineral density 12 months Lumbar bone mineral density (g/cm2) by DXA scan

Secondary

MeasureTime frame
Total hip bone mineral density 12 months Total hip bone mineral density (g/cm2) by DXA scan

Countries

Thailand

Contacts

Public ContactSumapa Chaiamnuay

Phramongkutklao hospital

sumapapmk@gmail.com0954459365

Outcome results

None listed

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