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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00909961

Enrollment

118

Registered

2009-05-29

Start date

2009-11-30

Completion date

2011-12-16

Last updated

2017-03-21

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

Conditions

Postmenopausal Osteoporosis

Keywords

Osteoporosis, Bone Mineral Density, Biomarkers

Brief 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.

Interventions

DRUGZoledronic acid

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

50 Years to 65 Years

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Efficacy - BMD	1 year

Secondary

Measure	Time frame
Efficacy - Biochemical markers	6 months
Safety - Rate of adverse events and serious adverse events	6 months

Countries

Turkey (Türkiye)

Outcome results

None listed

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