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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000218695

Enrollment

Registered

2005-08-26

Start date

2004-09-01

Completion date

Unknown

Last updated

2020-01-13

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 month study designed to determine the effect of rosiglitazone on bone metabolism

Interventions

8mg rosiglitazone daily over 3 months

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Postmenopausal 5 yrs or more.

Exclusion criteria

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.

Outcome results