The Duration of Action of Zoledronate study

A three year randomised, double-blind, placebo-controlled trial to determine the duration of effect of zoledronate on bone turnover markers and on bone density in post menopausal women with osteopenia.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000278639

Acronym

DAZE

Enrollment

Registered

2005-09-02

Start date

2005-04-26

Completion date

2006-03-02

Last updated

2024-12-02

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

Conditions

None listed

Brief summary

This is a 3 year study designed to determine the duration of action of a single dose of intravenous zoledronate.

Interventions

One infusion of 5mg intravenous zoledronate.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Postmenopausal 5 yrs or more, bone density T score between -1.0 and -2.0 at lumbar spine or total hip.

Exclusion criteria

Renal impairment (serum creatinine >0.15 mmol/L), chronic liver disease, untreated hypothyroidism or hyperthyroidism, concurrent major systemic illness, malignancy, active major gastrointestinal disease, metabolic bone diseases, or serum ALP > 2x normal limit, primary hyperparathyroidism, previous fragility fracture of the hip or spine. Use of oral glucocorticoid drugs equivalent to an average dose of prednisone 2.5 mg/day in the preceding 12 months, current or past use of bisphosphonate therapy, use of hormone replacement therapy within the last 12 months, use of other medication known to cause osteoporosis or interfere with bone metabolism.

Outcome results