Prospective Study of Profile of Hepatic Osteodystrophy in Patients With Non-Choleastatic Liver Cirrhosis and Impact of Bisphosphonate Supplementation

PROSPECTIVE STUDY OF PROFILE OF HEPATIC OSTEODYSTROPHY IN PATIENTS WITH NON-CHOLEASTATIC LIVER CIRRHOSIS AND IMPACT OF BISPHOSPHONATE SUPPLEMENTATION

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02249741

Enrollment

Registered

2014-09-26

Start date

2012-08-31

Completion date

2014-02-28

Last updated

2014-09-26

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

Conditions

Cirrhosis

Brief summary

Background and Objectives: Patients with liver cirrhosis are more prone to develop reduced bone mineral density i.e. hepatic osteodystrophy (HOD). It includes both osteopenia and osteoporosis and may lead to increased fracture risks. There is scanty data on prevalence of HOD in Indian population and its treatment outcome. The investigators aimed to determine prevalence of HOD, factors associated with it and the impact of bisphosphonates on bone mineral density in patients with liver cirrhosis. Patients and Methods: Consecutive patients with liver cirrhosis admitted at Sir Ganga Ram Hospital, New Delhi between August 2012 and July 2013 were enrolled. Patients with chronic kidney disease, hyperparathyroidism and those on steroids were excluded. Bone mineral density (BMD) was measured by dual-energy X-ray absorptiometry (DEXA) at the lumbar spine and femoral neck. Osteopenia and osteoporosis were defined according to WHO criteria. All patients also underwent 25-hydroxy-vitamin-D, sex hormone (testosterone in male and LH and Estradiol in female) and parathyroid hormone (PTH) along with routine investigations. Transient elastography was also done in all patients. Ibandronic acid 150 mg per day orally for six months was given in patients with osteoporosis and DEXA scan repeated.

Interventions

DRUGTreated with Ibandronic acid as per protocol

treated with Ibandronic acid at a dose of 150 mg once a month for six months

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Liver Cirrhosis 2. Age 18-70 years 3. Informed and written consent

Exclusion criteria

1. Chronic renal failure 2. Prolonged steroid use more than 3 months 3. Patients on immunosuppressive therapy 4. Primary hyperparathyroidism 5. Post menopausal women 6. Pregnancy 7. Cushing's syndrome 8. Malignancy 9. HIV Co-infection

Design outcomes

Primary

Measure	Time frame
Improvement in Bone Mineral Density on DEXA scan	6 months

Secondary

Measure	Time frame
Incidence of new fractures	6 months

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026