Health Condition 1: M810- Age-related osteoporosis without current pathological fracture Health Condition 2: M800- Age-related osteoporosis with current pathological fracture Health Condition 3: M818- Other osteoporosis without currentpathological fracture Health Condition 4: M808- Other osteoporosis with current pathological fracture Health Condition 5: M859- Disorder of bone density and structure, unspecified
Conditions
Interventions
Intervention1: Zoledronate plus dexamethasone.: Zoledronate 5 mg intravenous infusion single dose over 1-2 hours.
Dexamethasone 4 mg oral once daily for 3 days (on the day of infusion and two subsequ
Sponsors
AIIMS, Bhopal
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged 18 years or more Indication for the use of IV Zoledronate (such as osteoporosis) Receiving IV Zoledronate for the first time Willing to provide informed written consent
Exclusion criteria
Exclusion criteria: Pregnant and lactating females Known malignancy CKD with estimated GFR less than 35 ml/minute Steroid-induced osteoporosis or any use of glucocorticoids in the last 3 months Patients receiving immunomodulatory or anti-inflammatory medications History of acute illness in last 2 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in temperature change [from the morning on the day of infusion (day 0; pre-infusion) to the evening of the day after infusion (day 1; before dinner)] between the intervention and control arms.Timepoint: Day 0 in the morning, pre-infusion and day 1 in the evening, before dinner (where day 0 is the day of zoledronate infusion). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Difference in the proportion of participants in two arms who have a temperature increase from baseline to 100 degrees F (37.8 degrees C) in three days following the infusion, b) the difference in the proportion of participants needing rescue medications over the 3 days following the infusion, & c) the difference in acute phase reaction-symptom score between the two groups.Timepoint: The secondary outcomes are measured over three days following the infusion. | — |
Countries
India
Contacts
Public ContactDr Alpesh Goyal
All India Institute of Medical Sciences, Bhopal
Outcome results
None listed