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NCT00909961 Clinical Trial

A Trial Evaluating the Effects of Zoledronic Acid 5 mg Infusion on Bone Mineral Density (BMD) in Postmenopausal Osteoporosis (PMO) Patients Between the Ages of 50 and 65 Years

Postmenopausal Osteoporosis Clinical Trial

Official title:
A One Year, Local, Open Label, Multicentre Trial Evaluating the Effects of Zoledronic Acid 5 mg Infusion on BMD and Biochemical Markers of Bone in PMO Pts Between the Ages of 50 and 65 Years

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00909961
Other study ID # CZOL446HTR04
Secondary ID
Status Completed
Phase Phase 3
First received May 28, 2009
Last updated March 17, 2017
Start date November 2009
Est. completion date December 16, 2011

Study information
Verified date March 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the effects of zoledronic acid 5 mg infusion on BMD and biochemical markers of bone in post-menopausal osteoporotic patients aged between 50-65.

Recruitment information / eligibility
Status Completed
Enrollment 118
Est. completion date December 16, 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Female
Age group 50 Years to 65 Years
Eligibility Inclusion Criteria:

- Postmenopausal osteoporosis

- Patients who has a low bone mineral density at hip or vertebral

- Patients who has an osteoporotic fracture at hip or vertebra

Exclusion Criteria:

- Hypersensitivity either to the active substance or to any of the excipients or to any biphosphonates.

- Known metabolic bone disease excluding osteoporosis.

- Serious systemic disorder treated with drugs interfering with bone metabolism.

- Significant liver or renal failure

- Pathologic fracture in the examined body area or elsewhere.

- Previous anti-osteoporotic treatment within 12 months or less prior to the recruitment.

- Patients with hypocalcaemia

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Zoledronic acid

Locations
Country Name City State
Turkey Novartis Investigational site Ankara
Turkey Novartis Investigative site Antalya
Turkey Novartis Investigational site Istanbul
Turkey Novartis Investigative site Izmir
Turkey Novartis Investigative site Kayseri
Turkey Novartis Investigative site Konya

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy - BMD 1 year
Secondary Efficacy - Biochemical markers 6 months
Secondary Safety - Rate of adverse events and serious adverse events 6 months
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Completed NCT01668589 - Observational Study of Denosumab (Prolia®) in Postmenopausal Women With Osteoporosis N/A
Completed NCT04664959 - A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis Phase 3
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