Prospective Study of Profile of Hepatic Osteodystrophy in Patients With Non-Choleastatic Liver Cirrhosis and Impact of Bisphosphonate Supplementation
NCT ID: NCT02249741
Last Updated: 2014-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
47 participants
INTERVENTIONAL
2012-08-31
2014-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients with osteoporosis
Treated with Ibandronic acid as per protocol
Treated with Ibandronic acid as per protocol
treated with Ibandronic acid at a dose of 150 mg once a month for six months
Interventions
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Treated with Ibandronic acid as per protocol
treated with Ibandronic acid at a dose of 150 mg once a month for six months
Eligibility Criteria
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Inclusion Criteria
2. Age 18-70 years
3. Informed and written consent
Exclusion Criteria
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
18 Years
70 Years
ALL
No
Sponsors
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Dr. Ashish Kumar
OTHER
Responsible Party
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Dr. Ashish Kumar
Associate Professor
Locations
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Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
New Delhi, New Delhi, India
Countries
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Other Identifiers
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Gastro-2012-RB-1
Identifier Type: -
Identifier Source: org_study_id
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