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Zoledronic acid in patients with low bone mass.

Effect of 2 mg vs. 4 mg of intravenous zoledronic acid on bone mineral density at lumbar spine in Indian postmenopausal women with osteoporosis â?? A double blind parallel arm randomized control trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/05/008696
Enrollment
70
Registered
2017-05-30
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- Post menopausal Osteoporosis

Interventions

Intervention1: Group 1: 2 mg zoledronic acid will be given once at baseline intravenously over 15 minutes and bone mineral density will be measured at 12 months Control Intervention1: Group 2: 4 mg zo

Sponsors

JIPMER Intramural fund
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Post menopausal osteoporosis with T score at lumbar spine of -2.5 or less

Exclusion criteria

Exclusion criteria: 1.Evidence suggestive of secondary osteoporosis: a)parathyroid disorders, hyperthyroidism, Cushingâ??s disease, etc. b)drug history suggestive of usage of medications such as corticosteroids (either intravenous, oral or inhaled), anti-convulsants, anti-tubercular and other drugs causing osteoporosis; 2.Serum 25 (OH) D level less than 15 ng/ml. 3.Clinical and/or biochemical evidence of renal, liver or cardiac disease. 4.Autoimmune diseases such as rheumatoid arthritis, multiple sclerosis or SLE. 5.Systemic illness such AIDS/HIV. 6.Hematological disorders such as thalassemia, sickle cell disease, multiple myeloma, leukemia, lymphoma, etc. 7.History of cancer; 8.Previous or current treatment with bisphosphonates, teriparatide or any other medication known to affect skeleton.

Design outcomes

Primary

MeasureTime frame
Bone mineral density at lumbar spineTimepoint: 12 months

Secondary

MeasureTime frame
Bone mineral density at total hip, femoral neck and distal forearmTimepoint: 12 months;Bone turnover markersTimepoint: 12 months;Incidence of new fracturesTimepoint: 12 months

Countries

India

Contacts

Public ContactDr Sadish Kumar Kamalanathan

Jawaharlal Institute of Postgraduate Medical Education and Research

jppgi@yahoo.com9629158368

Outcome results

None listed

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