CompletedPhase 4ACTRN12605000218695

Effect of Rosiglitazone on Bone Metabolism

A three month randomised, double-blind, placebo-controlled trial to determine the effect of rosiglitazone on bone and calcium metabolism in normal post menopausal women.


Sponsor

Associate Professor A Grey

Enrollment

50 participants

Start Date

Sep 1, 2004

Study Type

Interventional

Conditions

Summary

This is a 3 month study designed to determine the effect of rosiglitazone on bone metabolism


Eligibility

Sex: Females

Inclusion Criteria1

  • Postmenopausal 5 yrs or more.

Exclusion Criteria1

  • Renal impairment (serum creatinine >0.15 mmol/L), congestive heart failure, 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, diabetes mellitus, primary hyperparathyroidism, > 2 hospital admission within 6 months of study entry. 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, current or past use of thiazolidinediones.

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Interventions

8mg rosiglitazone daily over 3 months

8mg rosiglitazone daily over 3 months


Locations(1)

New Zealand

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ACTRN12605000218695