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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-12-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Postmenopausal Osteoporosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zoledronic acid

Group Type EXPERIMENTAL

Zoledronic acid

Intervention Type DRUG

Interventions

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Zoledronic acid

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No