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Comparison of efficacy of Dexamethasone and acetaminophen for reducing the acute phase response after Zoledronate in postmenopausal osteoporosis

Comparison of efficacy of Dexamethasone and acetaminophen for reducing the acute phase response after Zoledronate in Postmenopausal Osteoporosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260715009
Enrollment
68
Registered
2026-07-15
Start date
2026-07-13
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 women with osteoporosis Postmenopausal osteoporosis, Acute phase response, Dexamethasone, Acetaminophen

Interventions

Dexamethasone group take a Dexamethasone 4 mg, 1.5 hr before get Zoledronate injection then take a Dexamethasone 4 mg in day 2,3 once a day in the morning ,Acetaminophen group take Acetaminophen 500
in the morning, noon, evening, bedtime (16:00, 22:00, 6:00, 12:00)
Active Comparator Drug,Active Comparator Drug
Dexamethasone,Acetaminophen

Sponsors

Mahawajiralongkorn foundation
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. postmenopausal women 45- 90 year old 2. Follow up osteoporosis treatment with Zoledronate at Phramongkutklao Hospital

Exclusion criteria

Exclusion criteria: 1. have underlying diseases as Diabetes mellitus, Glaucoma, myocardial infarction, poor controlled hypertension (BP > 160/90), Chronic kidney disease stage 4 (GFR < 30), Malignant tumor 2. Allergy to Glucocorticoids/ Acetaminophen/ NSAIDs 3. Active in clinical of infection or suspected in Acute or Chronic infection and immunocompromised patient

Design outcomes

Primary

MeasureTime frame
change of oral temperature from baseline within 72 hour after zoledronate injection degree celsius

Secondary

MeasureTime frame
clinical severity of acute phase response within 72 hour after zoledronate injection VAS score ,Rescue medication usage within 72 hour after zoledronate injection amount of used rescue medication ,incidence of acute phase response from Zoledronate within 72 hour after zoledronate injection percentage

Countries

Thailand

Contacts

Public ContactSuthita Phoesena

Orthopedics department of Phramongkutklao hospital and college of medicine

md_stt@hotmail.com0829594074

Outcome results

None listed

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