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Effect of zoledronate ( a medicine that decreases bone loss ) in bone loss occurring in patients with liver disease

Effect of zoledronate in hepatic osteodystrophy: a double blinded placebo controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/02/011761
Enrollment
44
Registered
2018-02-07
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: null- Chronic liver disease Health Condition 2: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: Zoledronate: Group 1:Calcium 1000 mg/d + Vitamin D 500 IU/d+ Single dose of 4 mg intravenous zoledronate in 100 ml normal saline Control Intervention1: Placebo: Group 2:Calcium 1000

Sponsors

JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Lumbar spine Z score less than or equal to -2

Exclusion criteria

Exclusion criteria: 1. Child C cirrhosis 2. Chronic Kidney disease 3.. Current steroid use 4. Primary Hyperparathyroidism 5. Cushing Syndrome 6. Malignancies (Except Hepatocellular Carcinoma) 7. HIV infection 8. Current vertebral fractures

Design outcomes

Primary

MeasureTime frame
To study the effect of zoledronate on change in bone mineral density at lumbar spine in male patients with hepatic osteodystrophy at 12 months follow upTimepoint: 6 & 12 months—

Secondary

MeasureTime frame
To evaluate the incidence of new fractures at 12 monthsTimepoint: 6 & 12 months;To study the effect of zoledronate on change in biochemical markers of bone turnoverTimepoint: 6 & 12 months;To study the effect of zoledronate on change in bone mineral density at total hip &neck of femur in male patients with hepatic osteodystrophyTimepoint: 6 & 12 months—

Countries

India

Contacts

Public ContactDr Jaya Prakash Sahoo

JIPMER

sadishkk@gmail.com9629528518

Outcome results

None listed

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