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To study the effects of Zoledronic acid on bone mineral density in Osteoporotic chronic spinal cord injury patients.

A randodomized double blinded case controlled study of the effects of Zoledronic acid on bone mineral density in Osteoporotic chronic spinal cord injury patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2007/091/000027
Enrollment
30
Registered
2008-01-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Osteoporosis in adults of age group 18- 60 years who are more than 12 months after traumatic spinal cord injury

Interventions

Intervention1: Zoledronic acid: single dose -4mg in 100ml normal saline given intravenously over half an hour Control Intervention1: Normal saline: single dose- 100ml, intravenously over half an hour

Sponsors

CMCVellore Research fund
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult males or females of age group 18-60 yrs more than 12 mths post traumatic spinal cord injury who have osteoporosis. Osteoporosis being defined as bone mneral density less than 2.5 standard deviations mean.

Exclusion criteria

Exclusion criteria: Features of non traumatic spinal cord injury, renal failure, heterotrophic ossification, pressure sores with osteomyelitis or history of treatment for osteoporosis

Design outcomes

Primary

MeasureTime frame
Change in bone mineral density as measured by DEXA scan 12 months after administration of Zoledronic acid.Timepoint: 0 - at diagnosis of osteoporosis and 12months after drug administration

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Shiela Mary Varghese

Student

drshielavarghese@yahoo.co.in8547863375

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026